MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6/60/90; PERIPHERAL DILATION CATHETER

Model Number 357467

Device Problem Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 01/10/2018

Event Type  Injury  

Event Description

Ous mdr - balloon ruptured into two parts during withdrawal.

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.The complaint instrument was returned in two parts.The distal balloon fragment is compressed, indicating that this part of the balloon got caught during the device withdrawal.The inner shaft has fractured proximal to the proximal x-ray marker and is severely elongated, indicating that a high tensile force was present.The balloon has burst transversally and several deep scratches were found on the balloon surface near the fracture site.The review of the manufacturing history of the production lot did not reveal any nonconformity.The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection, including both a leakage and pressure test.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined.The transversal burst pattern was most likely induced by the target lesion.

• Brand Name: PASSEO-18 6/60/90
• Type of Device: PERIPHERAL DILATION 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: 7244458
• MDR Text Key: 99122830
• Report Number: 1028232-2018-00334
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 357467
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11162945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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