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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939032252290
Device Problems Shaft; Kinked
Event Date 12/16/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by manufacturer: returned product consisted of a sterling balloon catheter, in 2 pieces and loaded onto an unidentified wire. The balloon was loosely folded, with the balloon folded back onto itself. The tip of the device was retracted back into the balloon body. There was contrast and blood in the device. Both markerbands are located on the device, with the proximal markerband located 5mm proximally from the prox weld. Microscopic and tactile inspection revealed a full separation 1mm from the strain relief. There is a separation of the outer shaft (separated. 5mm distally of the proximal weld) for 15. 5cm in length. The outer was stretched for 56 mm, over the area where the inner shaft was separated. Microscopic inspection revealed a separation of the inner 47mm proximal of the prox weld. The inner was separated for 25mm. Inner was stretched for 15. 5cm and locked onto the loaded, unidentified wire. Microscopic inspection found no irregularities or damage to the weld. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).

 
Event Description

Reportable based on device analysis completed on (b)(4) 2016. It was reported that shaft kink occurred. The target lesion was located in the anterior tibial artery (ata). A 2. 5x220x90 (4f) sterling balloon catheter was advanced and was noted to be kinked. The device was removed and another 2. 5x40x150 (4f) sterling balloon catheter was advanced but was also kinked. The procedure was then completed with a different device. No patient complications were reported and the patient's status was fine. However, returned device analysis revealed a shaft detachment.

 
Manufacturer Narrative

Correction -previously reported: the root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. Changed to - the most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

 
Event Description

Reportable based on device analysis completed on (b)(4) 2016. It was reported that shaft kink occurred. The target lesion was located in the anterior tibial artery (ata). A 2. 5x220x90 (4f) sterling balloon catheter was advanced and was noted to be kinked. The device was removed and another 2. 5x40x150 (4f) sterling balloon catheter was advanced but was also kinked. The procedure was then completed with a different device. No patient complications were reported and the patient's status was fine. However, returned device analysis revealed a shaft detachment.

 
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Brand NameSTERLING¿
Type of DeviceCATHETER, PERCUTANEOUS
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 Key5476133
Report Number2134265-2016-01079
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device MODEL NumberH74939032252290
Device Catalogue Number39032-25229
Device LOT Number0018579090
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/24/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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