MISSION KIT
Report
- Report Number
- 2020394-2025-01198
- Event Type
- Injury
- Date Received
- August 7, 2025
- Date of Event
- July 14, 2025
- Report Date
- August 8, 2025
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- PMA / PMN Number
- K171953
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: VADVALA HV, FURTADO VF, KAMBADAKONE A, FRENK NE, MUELLER PR, ARELLANO RS. IMAGE-GUIDED PERCUTANEOUS OMENTAL AND MESENTERIC BIOPSY: ASSESSMENT OF TECHNICAL SUCCESS RATE AND DIAGNOSTIC YIELD. J VASC INTERV RADIOL. 2017 NOV;28(11):1569-1576. DOI: 10.1016/J.JVIR.2017.07.001. EPUB 2017 SEP 13. PMID: 28916344. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. G3, H6 (PATIENT, COMPONENT) SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H11: VADVALA HV, FURTADO VF, KAMBADAKONE A, FRENK NE, MUELLER PR, ARELLANO RS. IMAGE-GUIDED PERCUTANEOUS OMENTAL AND MESENTERIC BIOPSY: ASSESSMENT OF TECHNICAL SUCCESS RATE AND DIAGNOSTIC YIELD. J VASC INTERV RADIOL. 2017 NOV;28(11):1569-1576. DOI: 10.1016/J.JVIR.2017.07.001. EPUB 2017 SEP 13. PMID: 28916344. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION / EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, " IMAGE-GUIDED PERCUTANEOUS OMENTAL AND MESENTERIC BIOPSY: ASSESSMENT OF TECHNICAL SUCCESS RATE AND DIAGNOSTIC YIELD", BIOPSIES WERE PERFORMED WITH COAXIAL TECHNIQUE USING 17-GAUGE COAXIAL INTRODUCER SYSTEM AND AN 18-GAUGE CUTTING NEEDLE FOR CORE SPECIMENS (BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT). THERE WERE 5 COMPLICATIONS, 2 MAJOR AND 3 MINOR. ALL 5 COMPLICATIONS WERE ENCOUNTERED IN THE MESENTERIC GROUP. THE 3 MINOR COMPLICATIONS CONSISTED OF MODERATE TO SEVERE PAIN AT THE SKIN PUNCTURE SITE, WHICH WAS MANAGED CONSERVATIVELY. COLONIC PERFORATION AND SUBSEQUENT ABSCESS FORMATION FOLLOWING A TRANSCOLONIC MESENTERIC BIOPSY WAS 1 OF THE 2 MAJOR COMPLICATIONS. A CT SCAN DEMONSTRATED AN INTRA-ABDOMINAL ABSCESS ADJACENT TO THE BIOPSY SITE. THE ABSCESS WAS MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE AND LATER THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LEFT COLECTOMY, AND COLOSTOMY. THE SECOND MAJOR COMPLICATION WAS A MESENTERIC HEMATOMA.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, " IMAGE-GUIDED PERCUTANEOUS OMENTAL AND MESENTERIC BIOPSY: ASSESSMENT OF TECHNICAL SUCCESS RATE AND DIAGNOSTIC YIELD", BIOPSIES WERE PERFORMED WITH COAXIAL TECHNIQUE USING 17-GAUGE COAXIAL INTRODUCER SYSTEM AND AN 18-GAUGE CUTTING NEEDLE FOR CORE SPECIMENS (BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT). THERE WERE 5 COMPLICATIONS, 2 MAJOR AND 3 MINOR. ALL 5 COMPLICATIONS WERE ENCOUNTERED IN THE MESENTERIC GROUP. THE 3 MINOR COMPLICATIONS CONSISTED OF MODERATE TO SEVERE PAIN AT THE SKIN PUNCTURE SITE, WHICH WAS MANAGED CONSERVATIVELY. COLONIC PERFORATION AND SUBSEQUENT ABSCESS FORMATION FOLLOWING A TRANSCOLONIC MESENTERIC BIOPSY WAS 1 OF THE 2 MAJOR COMPLICATIONS. A CT SCAN DEMONSTRATED AN INTRA-ABDOMINAL ABSCESS ADJACENT TO THE BIOPSY SITE. THE ABSCESS WAS MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE AND LATER THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LEFT COLECTOMY, AND COLOSTOMY. THE SECOND MAJOR COMPLICATION WAS A MESENTERIC HEMATOMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941184 | MISSION KIT | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |