MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939148308010

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the 3.0 mm x 80 mm x 150 cm sterling¿ sl balloon was advanced to the superficial femoral artery and inflated twice.The distal portion of the balloon tore off while inside the patient.There was an attempt to remove the detached portion however it could not be recovered.The fragment was then pressed against the vessel wall with a stent where it remains inside the patient.The patient was reported to be doing fine.

Manufacturer Narrative

Device evaluated by mfr.The returned product consisted of a sterling sl balloon catheter, the distal portion of the balloon was not returned.Device analysis determined the condition of the returned device was consistent with the complaint incident.The balloon has a longitudinal tear starting 2mm from the proximal markerband sand continues to the distal end of the torn balloon.The balloon is completely circumferentially torn off 30mm from the proximal balloon weld and the distal portion of the balloon was not returned.There are numerous shaft kinks.The inner shaft is stretched.The tip is damaged.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the 3.0mm x 80mm x 150cm sterling sl balloon was advanced to the superficial femoral artery and inflated twice.The distal portion of the balloon tore off while inside the patient.There was an attempt to remove the detached portion however it could not be recovered.The fragment was then pressed against the vessel wall with a stent where it remains inside the patient.The patient was reported to be doing fine.

• Brand Name: STERLING¿ SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7441481
• MDR Text Key: 105853608
• Report Number: 2134265-2018-03175
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: H74939148308010
• Device Catalogue Number: 39148-30801
• Device Lot Number: 21454182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1