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

Model Number H74939186252210

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

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 hole occurred.The target lesion was located in the tibial artery.A coyote balloon catheter was advanced for dilatation.However, upon inflation, the balloon inflated for a while and deflated by itself.After several attempts of inflating the balloon, the physician found that the balloon leaked from the shaft.The procedure was completed with another coyote balloon.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The balloon was loosely folded with blood in the balloon and lumen.Microscopic and tactile inspection revealed damage (perforation) to the inner shaft, 26cm from the tip of the device.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 hole occurred.The target lesion was located in the tibial artery.A coyote balloon catheter was advanced for dilatation.However, upon inflation, the balloon inflated for a while and deflated by itself.After several attempts of inflating the balloon, the physician found that the balloon leaked from the shaft.The procedure was completed with another coyote balloon.No patient complications were reported and the patient's status was stable.

• Brand Name: COYOTE¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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 Key: 5547921
• MDR Text Key: 41892345
• Report Number: 2134265-2016-02578
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H74939186252210
• Device Catalogue Number: 39186-25221
• Device Lot Number: 18609250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR