MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	39347-060450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code- lit, dqy.Initial reporter state: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for the shunt percutaneous angioplasty (pta) procedure.During the first inflation, however, the balloon ruptured.After decompression, the device was removed from the body and completed the procedure with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
D2b: product code- lit, dqy.E1: initial reporter state- (b)(6).Device analysis by manufacturer: athletis 6.0mm x 40mm x 50cm, 40atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 10mm proximal of the distal tip.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per athletis specification, the rated burst pressure for this device is 40 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for the shunt percutaneous angioplasty (pta) procedure.During the first inflation, however, the balloon ruptured.After decompression, the device was removed from the body and completed the procedure with another of same device.There were no patient complications reported.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14657862
• Report Number: 2134265-2022-06391
• Device Sequence Number: 3739173
• Product Code: LIT
• UDI-Device Identifier: 08714729973782
• UDI-Public: 08714729973782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201170
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 03/22/2025
• Device Model Number: 39347-060450
• Device Catalogue Number: 39347-060450
• Device Lot Number: 0029095377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (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
• Patient Sex: Unknown