DISPOSABLE SUTURE PLACEMENT SYSTEM

Report

Report Number: 3005099803-2011-00581
Event Type: Injury
Date Received: March 1, 2011
Date of Event: January 27, 2011
Report Date: February 1, 2011
Manufacturer: BOSTON SCIENTIFIC - MIAMI
Product Code: GCJ
PMA / PMN Number: K932553
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URINARY SLING (SLING TYPE AND MANUFACTURER UNKNOWN) PROCEDURE (PROCEDURE DATE UNKNOWN) USING A "CAPIO POLYPROPYLENE 0 BLUE MONOFILAMENT NONABSORBABLE SURGICAL SUTURE...(B)(4)," THE NEEDLE DETACHED FROM THE SUTURE WHEN THE SURGEON WAS ANCHORING THE SLING, "FORCING THE SURGEON TO LEAVE THE [NEEDLE] INSIDE THE PATIENT." THE TYPE OF SUTURING DEVICE USED WITH THE CAPIO SUTURE WAS NOT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SUTURE CAPTURING DEVICE (TYPE UNKNOWN) WAS USED WITHIN THE PELVIS FOR THE PROCEDURE. THE SUTURE BROKE "CLEANLY" AT THE NEEDLE. THE SPECIFIC LOCATION OF THE DETACHED NEEDLE WITHIN THE PATIENT WAS NOT IDENTIFIED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS SAME CAPIO DEVICE, WITH NO FURTHER COMPLICATIONS TO THE PATIENT. REGARDING THE PATIENT'S POST-OPERATIVE CONDITION, THE PHYSICIAN REPORTED THAT SHE HAS "NO COMPLAINTS."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DISPOSABLE SUTURE PLACEMENT SYSTEM	LAPAROSCOPE, GENERAL & PLASTIC SURGERY	GCJ	BOSTON SCIENTIFIC - MIAMI	UNK55

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Other