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

Model Number 39347-120470

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation, it was noted that balloon ruptured before reaching rated burst pressure.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionizes water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification, the rated burst pressure for this device is 20 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was kinked at approximately 330mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture occurred.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during inflation, it was noted that balloon ruptured before reaching rated burst pressure.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19046319
• MDR Text Key: 339563441
• Report Number: 2124215-2024-16267
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729974260
• UDI-Public: 08714729974260
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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
• Device Operator: Health Professional
• Device Model Number: 39347-120470
• Device Catalogue Number: 39347-120470
• Device Lot Number: 0029395792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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