PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-06170
- Event Type
- Injury
- Date Received
- June 3, 2025
- Date of Event
- December 8, 2023
- Report Date
- June 3, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT:(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: ANN AM THORAC SOC. 2024 MAY;21(5):823-826. DOI: 10.1513/ANNALSATS.202306-580CC. PMID: 38691004. HTTPS://DOI.ORG/10.1513/ANNALSATS.202306-580CC.
PLEURAL PORT-A-CATH FOR SYMPTOMATIC REFRACTORY HEPATIC HYDROTHORAX IN NONTRANSPLANT LIVER PATIENTS. THIS IS A CASE STUDY OF 61-YEAR-OLD MAN WITH A HISTORY OF PRIMARY BILIARY CIRRHOSIS AND DECOMPENSATED END-STAGE LIVER DISEASE WAS ADMITTED WITH LARGE RIGHT PLEURAL EFFUSION AND DYSPNEA AND A 72-YEAR-OLD WOMAN WITH A HISTORY OF NONALCOHOLIC STEATOHEPATITIS CIRRHOSIS WITH DECOMPENSATED LIVER FAILURE PRESENTED TO THE INTERVENTIONAL PULMONARY CLINIC FOR EVALUATION OF RECURRENT HEPATIC HYDROTHORAX. THESE PATIENTS UNDERWENT PAC INSERTION PROCEDURE WHILE USING 3¿0 PROLENE SUTURES AND ABSORBABLE SUTURES (2¿0 VICRYL DEEP AND 3¿0 VICRYL SUPERFICIAL; ETHICON). REPORTED COMPLICATIONS ARE N=1; 72-YEAR-OLD WOMAN -CELLULITIS IN CONCLUSION, PAC INSERTION IS AN ALTERNATIVE OPTION FOR PATIENTS WITH REFRACTORY HEPATIC HYDROTHORAX WHO ARE NOT CANDIDATES FOR TRANSPLANTATION OR TIPS CREATION. IT CAN BE PARTICULARLY USEFUL FOR PATIENTS WITH A CHALLENGING BODY HABITUS OR WHO ARE ANXIOUS ABOUT UNDERGOING REPEATED PROCEDURES. IT REQUIRES TRAINED PERSONNEL TO CARE FOR THE PATIENT, BUT, WHEN THE PROCEDURE IS DONE PROPERLY, IT CAN OFFER SYMPTOM RELIEF WITH A MINIMAL RISK OF COMPLICATIONS. LARGER STUDIES ARE WARRANTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF PAC PLACEMENT IN PATIENTS WITH REFRACTORY HEPATIC HYDROTHORAX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1064450 | PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |