MAUDE Adverse Event Report: CREAGH MEDICAL BIOTRONIK PASSEO-35 HP; PTA CATHETER

Model Number	10/40/75
Medical Device Problem Codes	Material Fragmentation (1261); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The 10mm high pressure balloon burst while inflating at the rated burst pressure, 20atm.The balloon fragment was stuck in the vein fibrotic tissue and was unable to be removed.It was also noted that a part of the balloon was also stuck at the tip of the guide sheath.Some force was applied to remove the balloon catheter and guide sheath from the vein.Parts of the balloon were also broken and stuck in the patient anatomy near the puncture site.A venous cut down was preformed to remove the remaining balloon.No balloon fragments remained in the patient anatomy.The reported issue resulted in prolonged patient hospitalization.A permanent catheter was also inserted into the patient for dialysis due to the trauma sustained to the fistula brachial cephalic vein.It was noted the lesion location was located distally.The approximate vessel diameter was reported to be 10mm with a stenosis degree of 70% and lesion length of 60mm.The vessel had mild tortuosity and severe calcification.
Additional Manufacturer Narrative
Correction: b5 updated.H3: device analysis confirmed the reported issue.The balloon catheter was returned in four segments.When the segments were aligned, elongation was observed that likely occurred during device removal from the patient anatomy.The original balloon catheter had a working length of approximately 75cm.The returned segments had a total length of 90cm.The balloon appeared to burst radially.Due to being in several segments, the exact point of origin could not be determined.However, the initial break likely occurred at the proximal end, near the main catheter body.The subsequent breaks that occurred near the distal end of the balloon likely occurred during additional required intervention for retrieval.The reported issue was likely related to the length of the balloon (40mm) being an insufficient length to cover the 60mm lesion.Several inflation cycles were needed to cover the entire lesion length.The need for several cycles and movement through highly a calcified vessel likely contributed to the failure.
Event or Problem Description
The 10mm high pressure balloon burst while inflating at the rated burst pressure, 20atm, during a fistulaplasty procedure.The balloon fragment was stuck in the vein fibrotic tissue and was unable to be removed.It was also noted that a part of the balloon was also stuck at the tip of the guide sheath.Some force was applied to remove the balloon catheter and guide sheath from the vein.Parts of the balloon were also broken and stuck in the patient anatomy near the puncture site.A venous cut down was preformed to remove the remaining balloon.No balloon fragments remained in the patient anatomy.The reported issue resulted in prolonged patient hospitalization.A permanent catheter was also inserted into the patient for dialysis due to the trauma sustained to the fistula brachial cephalic vein.It was noted the lesion location was located distally.The approximate vessel diameter was reported to be 10mm with a stenosis degree of 70% and lesion length of 60mm.The vessel had mild tortuosity and severe calcification.The problem device was used for more than five inflation cycles before failure.There was no further impact to patient.

• Brand Name: BIOTRONIK PASSEO-35 HP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007000
• MDR Report Key: 16133573
• Report Number: 3005994106-2023-00001
• Device Sequence Number: 18023502
• Product Code: LIT
• UDI-Device Identifier: 05391525781600
• UDI-Public: 05391525781600
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2024
• Device Model Number: 10/40/75
• Device Catalogue Number: 399096
• Device Lot Number: 22103079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male