MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7518

Device Problems Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

It was reported that device contamination occurred.A 2.50mm x 12mm apex balloon catheter was selected for use.However, during unpacking, it was noticed that the package was damaged.The inner pouch of the package was not intact and a visible hole was observed.The sterility of the device was compromised.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

Event Description

It was reported that device contamination occurred.A 2.50mm x 12mm apex balloon catheter was selected for use.However, during unpacking, it was noticed that the package was damaged.The inner pouch of the package was not intact and a visible hole was observed.The sterility of the device was compromised.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

The returned product consisted of an apex balloon catheter and packaging.The packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The boston scientific corporation (bsc) seal on the pouch was intact.There was a cut across the pouch above the bsc seal.There was no damage to the device.There was no carrier tube returned with the device.The devices balloon protector was missing.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: APEX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10626673
• MDR Text Key: 209782483
• Report Number: 2134265-2020-13306
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729475491
• UDI-Public: 08714729475491
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Model Number: 7518
• Device Catalogue Number: 7518
• Device Lot Number: 0021155281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 61