FDA Adverse Event Malfunction Summary report: N

HTA PROCERVA PROCEDURE SET

MDR report key: 1513213 · Received October 13, 2009

Report

Report Number: 3005099803-2009-04797
Event Type: Malfunction
Date Received: October 13, 2009
Date of Event: September 4, 2009
Report Date: September 19, 2009
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: MNB
PMA / PMN Number: P000040
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER IS NOT KNOWN, THEREFORE, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. THE COMPLAINANT HAS INDICATED THAT SUSPECT DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, FOLLOW UP INFORMATION RECEIVED ON 09/19/2009 REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THE FOLLOW UP INFORMATION. A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS BEING PREPARED FOR A HYDROTHERMABLATION (HTA) PROCEDURE. ACCORDING TO THE COMPLAINANT, "DURING SET UP, THE STRIKER ADAPTOR WOULD NOT SIT ON THE HTA SHEATH". FOLLOW UP INFORMATION RECEIVED ON 09/19/2009 REVEALED THAT ADAPTER DID NOT PROPERLY THREAD ONTO SHEATH, AND THE ADAPTER ONLY PARTIALLY TURNED ONTO THE THREADS OF THE SHEATH, THEREFORE, SMALL AMOUNTS OF FLUID DRIPPED OUT. THE PROCEDURE WAS ABORTED AND A DIFFERENT PROCEDURE WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HTA PROCERVA PROCEDURE SET		MNB	BOSTON SCIENTIFIC CORPORATION	M006560211

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK