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

Model Number 24715

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that catheter entrapment on guidewire occurred. Vascular access was obtained via crossover approach. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted. A 6. 0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent. Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times. However, during removal, the balloon was stuck with the guide wire and it could not be removed. Subsequently, the device was removed as a set with the guidewire and the procedure was completed. No patient complications nor injuries were reported.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11362093
• MDR Text Key: 233050429
• Report Number: 2134265-2021-02151
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/26/2021
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0025479424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial