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

Model Number H74939186400810

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.

• 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: 7352911
• MDR Text Key: 102894722
• Report Number: 2134265-2018-01918
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939186400810
• Device Catalogue Number: 39186-40081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention