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

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.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6601015
• MDR Text Key: 76284323
• Report Number: 2134265-2017-05241
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• 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 Received: 05/31/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/29/2020
• Device MODEL Number: H74939186401510
• Device Catalogue Number: 39186-40151
• Device LOT Number: 20282052
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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