MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/120/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	383279
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 balloon was selected for treatment of a severely calcified lesion (80 percent stenosis degree) in the mildly tortuous sfa.The balloon was inflated at 4 bar and the pressure could not be increased anymore.During the attempt to deflate and inflate the balloon again, blood appeared in the syringe of the inflation device.The balloon was confirmed burst when it was taken out and flush with saline.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.As part of the technical investigation functional testing was performed.During inflation the balloon opened, but the pressure could not be held due to a fine jet water emerging from the proximal part of the balloon.Microscopic analysis of the balloon surface revealed a small pinhole with transversal orientation about 29 mm distal to the proximal x-ray marker.A long deep scratch and several small scratches were observed in close vicinity to the pinhole.It therefore seems likely that the damage of the balloon surface was caused by a hard, sharp-edged object pressing against the balloon from the outside.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the reported complaint event is most likely related to the patients anatomy (i.E.Severe calcification).

• Brand Name: PASSEO-35 6/120/130
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11860318
• Report Number: 1028232-2021-02754
• Device Sequence Number: 16892833
• Product Code: LIT
• UDI-Device Identifier: 07640130434615
• UDI-Public: 07640130434615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Expiration Date: 06/30/2021
• Device Model Number: 383279
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05186631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1