MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.A 3.0 x 220 x 90 (4f) sterling balloon was selected for use.During removal, the guide broke making the removal of the balloon impossible.The hospitalization took longer as the patient was given local anesthesia and additional surgical intervention was reformed to remove the guide.
Event or Problem Description
It was reported that removal difficulty occurred.A 3.0x220x90 (4f) sterling balloon was selected for use.During removal, the guide broke making the removal of the balloon impossible.The hospitalization took longer as the patient was given local anesthesia and additional surgical intervention was reformed to remove the guide.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The proximal portion of the device was missing.Approximately 175mm of the distal portion was returned.The inner shaft was separated 30mm from the tip.There was blood in the balloon.The balloon had a circumferential tear 175mm from the tip.The was a longitudinal tear starting at the circumferential tear and extending 39mm distally.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10121090
• Report Number: 2134265-2020-07318
• Device Sequence Number: 19368811
• Product Code: LIT
• UDI-Device Identifier: 08714729860181
• UDI-Public: 08714729860181
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: 04/12/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0024596560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1