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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 H74939186400810
Device Problems Balloon; Detachment Of Device Component; Material Rupture; Tip
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. 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 ruptured and balloon tip detachment occurred. Vascular access was obtained via the dorsalis pedis. The target lesion was located in the superficial femoral artery (sfa). After a guide wire crossed the lesion in bare back over-the-wire with no sheath "coral reef type calcium, very hard" in the sfa, a 4. 0 mm x 80 mm x 150 cm coyote¿ balloon catheter was advanced for dilation. However, during inflation at over rated burst pressure, the balloon ruptured. When the device was removed, it was noted that the tip of the catheter broke off of the balloon catheter. The physician was unable to capture the detached tip and left inside the patient's body. No further patient complications were reported.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that snaring was performed to retrieve the detached tip of the 4. 0mm x 80mm x 150cm coyote balloon catheter but was unsuccessful and remains in the superficial femoral artery.

 
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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 Key7352911
Report Number2134265-2018-01918
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939186400810
Device Catalogue Number39186-40081
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/20/2018 Patient Sequence Number: 1
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