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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939186401510
Device Problems Balloon (419); Detachment Of Device Component (1104); Material Rupture (1546); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 balloon rupture and detachment occurred. The target lesion was located in the heavily calcified superficial femoral artery (sfa). A 4. 0mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced to dilate the lesion. However, upon the first inflation at 10 atmospheres, the balloon ruptured circumferentially and separated from the catheter. The separated balloon and the tip of the catheter were retrieved using a snare. The procedure was then completed with a different device. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of the emerge balloon catheter in two pieces with a snare device. The shafts, balloon and tip were microscopically examined. There was blood in the inflation lumen, guidewire lumen and balloon. The balloon was loosely folded. The snare device was attached to the balloon of the device. Majority of the shaft was buckled and stretched. The inner shaft that would be within the balloon, had a completed separation and the shaft was torn distally of the separation. Due to the shaft being stretched, a measurement could not be obtained. The damage to the shaft indicates that the separation was due to tensile overload. The balloon was bunched up and had a complete circumferential tear 2 mm distal of the proximal balloon transition. The tip was damaged. 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. Device analysis determined the condition of the returned device was consistent with the reported information. There is no indication that the device was inflated over the rated burst pressure (rbp). 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 balloon rupture and detachment occurred. The target lesion was located in the heavily calcified superficial femoral artery (sfa). A 4. 0mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced to dilate the lesion. However, upon the first inflation at 10 atmospheres, the balloon ruptured circumferentially and separated from the catheter. The separated balloon and the tip of the catheter were retrieved using a snare. The procedure was then completed with a different device. No patient complications were reported and the patient's status was fine.

 
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Brand NameCOYOTE¿
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 Key6601015
MDR Text Key76284323
Report Number2134265-2017-05241
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device MODEL NumberH74939186401510
Device Catalogue Number39186-40151
Device LOT Number20282052
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2017
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: 05/31/2017 Patient Sequence Number: 1
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