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

Model Number	7518
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10626673
• Report Number: 2134265-2020-13306
• Device Sequence Number: 11564391
• Product Code: LOX
• UDI-Device Identifier: 08714729475491
• UDI-Public: 08714729475491
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 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
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 61