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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 H74939032601510
Device Problems Shaft; Break
Event Date 08/31/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the very heavily calcified superficial femoral artery. After a 6f non-bsc guiding sheath, a 6. 0x150x150 sterling¿ balloon catheter was advanced to dilate the lesion. Following successful dilatation, the physician pulled the balloon back into the 6f non-bsc guiding sheath. However, the balloon was caught on some of the heavy calcium and a part of the balloon broke off, and was left inside the patient's body. The patient was sent to surgery to remove the broken part of the device. The procedure was completed with no further patient complications reported and the patient's status was fine.

 
Manufacturer Narrative

Device evaluated by mfr. : returned device consisted of a sterling balloon catheter loosely folded with the distal tip and some of the balloon missing. Part of the inner was separated from the device with one of the markerband loose from the device. Part of the inner had separated from the shaft and extremely stretched. There was blood and contrast in the inflation lumen. Inspection under magnification revealed that the balloon circumferentially burst. There were no irregularities in the balloon material that could have contributed to the tear. No proximal weld damage was found. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors. (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the very heavily calcified superficial femoral artery. After a 6f non-bsc guiding sheath, a 6. 0x150x150 sterling balloon catheter was advanced to dilate the lesion. Following successful dilatation, the physician pulled the balloon back into the 6f non-bsc guiding sheath. However, the balloon was caught on some of the heavy calcium and a part of the balloon broke off, and was left inside the patient's body. The patient was sent to surgery to remove the broken part of the device. The procedure was completed with no further patient complications reported and the patient's status was fine.

 
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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 Key5113218
Report Number2134265-2015-06492
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device MODEL NumberH74939032601510
Device Catalogue Number39032-60151
Device LOT Number17477467
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/12/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/30/2015 Patient Sequence Number: 1
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