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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939134152010
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon rupture and detachment occurred. The target lesion was located in the strongly calcified fibular artery. A 1. 5mm x 20mm x 142cm coyote¿ es balloon catheter was advanced for dilation. However, during the first inflation at 8 atmospheres for 30 seconds, the balloon ruptured. The device was removed and a part of the balloon stayed within the sheath. The procedure was completed with a different device. No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr. : returned product consisted of a coyote es balloon catheter with the inner shaft and balloon not returned. The outer shaft, and inner shaft were microscopically examined. The inner shaft is separated under the hub and was not returned, the fractured/separated end of the inner shaft is stretched and jagged which indicates the shaft separation was due to tensile forces. The balloon has been torn off of the distal outer shaft at the proximal balloon bond, the balloon is torn and jagged which indicates tensile force/stress prior to the balloon being separated. Examination of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that balloon rupture and detachment occurred. The target lesion was located in the strongly calcified fibular artery. A 1. 5mm x 20mm x 142cm coyote¿ es balloon catheter was advanced for dilation. However, during the first inflation at 8 atmospheres for 30 seconds, the balloon ruptured. The device was removed and a part of the balloon stayed within the sheath. The procedure was completed with a different device. No patient complications were reported and the patient's status was good.
 
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Brand NameCOYOTE¿ ES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7550618
MDR Text Key109449300
Report Number2134265-2018-04716
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K080982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/09/2020
Device Model NumberH74939134152010
Device Catalogue Number39134-15201
Device Lot Number21970016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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