MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24702
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that catheter entrapment on the guidewire occurred.A 3.0mm x 100mm x 150cm sterling sl balloon catheter and v-18 guidewire were selected for a procedure below the knee.There was difficulty advancing the sterling sl balloon catheter over the v-18 guidewire.The device became stuck on the guidewire.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that catheter entrapment on the guidewire occurred.A 3.0mm x 100mm x 150cm sterling sl balloon catheter and v-18 guidewire were selected for a procedure below the knee.There was difficulty advancing the sterling sl balloon catheter over the v-18 guidewire.The device became stuck on the guidewire.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The balloon was tightly folded.Microscopic inspection revealed tip damage.The device was functionally tested with a.018" guidewire and no issues were detected.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10058053
• Report Number: 2134265-2020-06452
• Device Sequence Number: 3293534
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 08/13/2021
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0024263732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/18/2020
• Patient Sequence Number: 1