MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP90820B0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was a reported that a balloon detachment occurred and the patient required surgery.A 2cm peripheral cutting balloon¿ was selected for a procedure in the superficial femoral artery (sfa).During the procedure, the balloon detached from the catheter shaft inside the patient.The balloon was removed from the iliaca externa through surgery.There were no patient complications reported.The patient had no problems after surgery.

Manufacturer Narrative

Device evaluated by mfr: device analysis found a complete break in the catheter of the device.The proximal section of the device consisting of catheter and hub was returned for analysis.The detached distal section consisting of the tip, blades, markerbands, balloon material, balloon bond and distal catheter was not returned for analysis.The returned section of the device was received still loaded onto the customer¿s guidewire.Blood was observed within the lumen of the device.A visual and tactile examination identified a complete break in the shaft approximately 1210mm distal to the strain relief on the outer catheter and 1230mm distal to the strain relief on the inner catheter.Severe kinking and stretching damage was also noted along the length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.The investigator could not remove the customer¿s guidewire from the device due to the severe stretching and kinking damage identified on the catheter.No issues were noted with the catheter that could have contributed to the complaint incident.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 cause of the reported difficulties could not be determined.(b)(4).

Event Description

It was a reported that a balloon detachment occurred and the patient required surgery.A 2cm peripheral cutting balloon was selected for a procedure in the superficial femoral artery (sfa).During the procedure, the balloon detached from the catheter shaft inside the patient.The balloon was removed from the iliaca externa through surgery.There were no patient complications reported.The patient had no problems after surgery.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6739708
• MDR Text Key: 80884680
• Report Number: 2134265-2017-07239
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2019
• Device Model Number: M001BP90820B0
• Device Catalogue Number: BP908020B
• Device Lot Number: 0020309677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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): Required Intervention