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

Model Number H74939135252010

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.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 catheter entrapment and shaft break occurred.After a non-bsc guidewire crossed the moderately tortuous lesion, a 2.5 mm x 20 mm x 144 cm coyote¿ es balloon catheter was advanced to dilate the lesion.However, the device became stuck midway and could not be removed.Subsequently, the device was removed together with the guidewire.When the balloon was attempted to release from being stuck with the guide wire, the shaft got detached.The procedure was not completed.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of the coyote es balloon catheter in two pieces with portion of an.014¿ unidentified guidewire.The distal portion of the coyote es was received on the guidewire.The hypotube, balloon, tip and shaft were microscopically examined.The balloon was loosely folded.The shaft was buckled in numerous locations throughout the inner shaft.The balloon was bunched up.The tip was damaged.The shaft was separated at the exit notch.The separated ends appeared to be jagged and damaged, which indicates that the separation was due to tensile overload.The inner diameter (id) of the catheter was measured at the exit notch which is within the coyote es specifications.An attempt was made to remove the guidewire from the distal portion of the device; however, due to the damaged shaft the wire was unable to be removed.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.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 catheter entrapment and shaft break occurred.After a non-bsc guidewire crossed the moderately tortuous lesion, a 2.5mm x 20mm x 144cm coyote¿ es balloon catheter was advanced to dilate the lesion.However, the device became stuck midway and could not be removed.Subsequently, the device was removed together with the guidewire.When the balloon was attempted to release from being stuck with the guide wire, the shaft got detached.The procedure was not completed.No patient complications were reported.

• Brand Name: COYOTE¿ ES
• Type of Device: CATHETER, 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 Key: 6471964
• MDR Text Key: 72143292
• Report Number: 2134265-2017-03155
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: H74939135252010
• Device Catalogue Number: 39135-25201
• Device Lot Number: 0018803590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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