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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939148408010
Device Problems Shaft; Break; Device Damaged Prior to Use
Event Date 11/01/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft break occurred. During unpacking of a 4. 0mm x 80mm x 150cm sterling sl balloon catheter, the balloon protector did not fully cover the balloon and it was noted that the shaft was broken. The procedure was completed with another of the same device. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter. The balloon was loosely folded. The shaft is intact and is not broken. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous shaft kinks. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure (rbp). The sterling sl device inflated and held pressure for 5 minutes, without leaking. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).

 
Event Description

It was reported that shaft break occurred. During unpacking of a 4. 0mm x 80mm x 150cm sterling sl balloon catheter, the balloon protector did not fully cover the balloon and it was noted that the shaft was broken. The procedure was completed with another of the same device. No patient complications were reported.

 
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Brand NameSTERLING¿ SL
Type of DeviceCATHETER, 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 Key7049851
Report Number2134265-2017-11512
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device MODEL NumberH74939148408010
Device Catalogue Number39148-40801
Device LOT Number0020497939
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/10/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2017
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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