MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 3MM X 10MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC03100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1st of 2 reports.Device not returned.
Event or Problem Description
It was reported that during procedure, the first balloon catheter (subject device) was ruptured.The first balloon was removed from the patient's body and replace with a 2nd balloon catheter.During use of the 2nd balloon catheter, extravasation was observed.No additional information is available currently.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.The information provided in the complaint indicated that there were no anomalies noted to the device prior to use.It is possible that the device may have been over inflated during the procedure; however, this cannot be definitively determined.An assignable cause of undetermined was assigned to the as reported event 'balloon burst/ruptured' as a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause and the device was not returned for analysis.
Event or Problem Description
It was reported that a patient was hospitalized due to subarachnoid hemorrhage and during the procedure, the first balloon catheter (subject device) was ruptured.The first balloon was removed from the patient's body and replace with a 2nd balloon catheter.The patient suffered from extravasation and a drain was opened.One day following the procedure, the patient¿s family elected to withdraw care and the patient expired.The physician does not believe the extravasation and patient¿s death was caused by the stryker devices used during the procedure.

• Brand Name: TRANSFORM COMPLIANT 3MM X 10MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7765553
• Report Number: 3008881809-2018-00335
• Device Sequence Number: 19152562
• Product Code: MJN
• UDI-Device Identifier: 07613327004410
• UDI-Public: 07613327004410
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003SRC03100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFORM BALLOON CATHETER (STRYKER)
• Patient Age: 75 YR