MAUDE Adverse Event Report: COOK UROLOGICAL INC BAKRI TAMPONADE BALLOON CATHETER; INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOS-100500

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Uterine Perforation (2121)

Event Date 06/09/2014

Event Type  Injury  

Event Description

A female pt with hypertension during pregnancy underwent hemostasis after postpartum hemorrhage on (b)(6), 2014.The device was placed percutaneously to treat postpartum bleeding after the cesarean section.With the pt's pain complaint received 22~23 hours after the placement, ct was performed and it confirmed that the device penetrated the uterus and got embedded into it.The device was immediately removed with laparotomy.Since bleeding had not been stopped, uae was performed.There have been no adverse effects to the pt reported.

Manufacturer Narrative

(b)(4).Event eval: still under investigation.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, dir ; p.o. box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 3925718
• MDR Text Key: 4516224
• Report Number: 1820334-2014-00293
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2014

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 Expiration Date: 12/31/2016
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: U2433341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2014
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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): Required Intervention