MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 5/20/90; PERIPHERAL DILATATION CATHETER

Model Number 357455

Device Problems Burst Container or Vessel (1074); Fracture (1260)

Patient Problem Hematoma (1884)

Event Date 09/28/2016

Event Type  malfunction  

Event Description

Ous mdr - during inflation of the passeo-18 5/20/90 balloon in an av fistula with 15 atm, the balloon ruptured.During removal the ruptured segment fractured.The left brachial artery was punctured and the fragment could be successfully removed into the exchanged 8 f sheath.No device parts remained in the patient.The patient developed a hematoma.

Manufacturer Narrative

The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Only the proximal part comprising of the shaft and the proximal part of the balloon was returned for technical analysis.According to the received information the distal fractured part was successfully removed and no device parts remained in the patient.The balloon shows a transversal fracture in the cylindrical balloon part.Microscopic analysis of the balloon surface revealed several deep scratch marks close to the fracture site.The inner shaft was found ruptured proximal to the proximal x-ray marker.Review of the production documentation of the product verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause was determined.Due to the transversal scratches in close vicinity of the fracture site it is assumed that the rupture of the balloon was most likely induced by the sharply angulated stenosis.

• Brand Name: PASSEO-18 5/20/90
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6002662
• MDR Text Key: 56798949
• Report Number: 1028232-2016-03961
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357455
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02164247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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