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

Model Number H74939148308010

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the balloon radiopaque marker could not be seen under fluoroscopy.The target lesion was located in the anterior tibial artery.A 3.0mm x 80mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation.However, during advancement of the catheter before reaching the target vessel, the radiopaque marker was not visible under x-ray.The balloon was never inflated and the device was completely removed from the patient.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter.Microscopic and tactile inspection revealed numerous kinks in the shaft.Microscopic and visual inspection found the balloon was tightly folded.The marker bands were found to be in the correct positions and were undamaged.Inspection of the remainder of the device revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty seeing the marker band, which could not be confirmed because the clinical circumstances could not be replicated.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the balloon radiopaque marker could not be seen under fluoroscopy.The target lesion was located in the anterior tibial artery.A 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during advancement of the catheter before reaching the target vessel, the radiopaque marker was not visible under x-ray.The balloon was never inflated and the device was completely removed from the patient.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5766451
• MDR Text Key: 48716439
• Report Number: 2134265-2016-05711
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: H74939148308010
• Device Catalogue Number: 39148-30801
• Device Lot Number: 17754817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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
• Patient Age: 83 YR