MAUDE Adverse Event Report: COOK BIOTECH, INC. BIDESIGN 4-LAYER TISSUE GRAFT; SURGISIS ES

Catalog Number C-SLH-4S-7X10

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/10/2014

Event Type  Injury  

Event Description

The pt underwent repair of recurrent cystocele on (b)(6) 2014, performed at (b)(6) hospital, with placement of a biodesign 4-layer tissue graft, a cystoscopy was not performed intraoperatively.Postoperative clinical and radiological signs of constriction of the left ureter were present.On the third postoperative day, the pt was reoperated on a suture were loosened.The pt experienced an extended hospitalization, pain and discomfort.Current pt status unk.The product remained implanted in the pt.

Manufacturer Narrative

Conclusions - root cause.Investigation into this feedback included, a review of the feedback details received, communication with european complaint handling, and a review of the biodesign tissue graft ifu fp0005-04h.The root cause, of the constriction of the pt's left ureter, appears to be related to the amount of tension the user placed on sutures.The device ifu instructs the user to "transfer the graft to the graft site and suture or staple into place, avoid excess tension." it is possible that had an intraoperative cystoscopy been performed, at the time of placement of the device, constriction of the left ureter may have been identified and corrected.

• Brand Name: BIDESIGN 4-LAYER TISSUE GRAFT
• Type of Device: SURGISIS ES
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906-1000 ; 7654973355
• MDR Report Key: 3692642
• MDR Text Key: 16914464
• Report Number: 1835959-2014-00019
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-SLH-4S-7X10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention