MAUDE Adverse Event Report: ANGIOSCORE, INC ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, ANGIOPLASTY, PERIPHERAL

Model Number 2076-5040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.Lab analysis confirmed a distal bond peel but remained intact to the device.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.Report source: foreign- (b)(4).The angiosculpt device was returned for evaluation.Visual examination confirmed a distal bond peel but remained intact to the device.During functional testing, the balloon was inflated to 8 atm and a misaligned scoring element was observed.With the balloon inflated, the marker bands appeared to be within the 40 mm working length of the balloon.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

During inflation in the sfa, the physician noticed that the marker bands were out of place and did not indicate the correct balloon working length.However, the procedure was completed by the relevant balloon catheter.The angiosculpt was returned for evaluation.Visual examination confirmed a distal bond peel but remained intact to the device.

Manufacturer Narrative

The balloon working length was measured using a microvu scope and was determined to be out of spec.In normal lab investigation practice, a ruler is used to measure the balloon working length which met specification; however, for this particular case, additionally a microvu scope was used for a more precise measurement.The scoring element was removed from the balloon to accurately measure the balloon working length.Using a microvu scope, the balloon working length was measured three times (41.6707, 41.7060, and 41.8210) and was determined to be out of spec.The balloon working length specification is 40 mm +/- 1.5 mm.

Manufacturer Narrative

The patient codes and device code were not included in the initial mdr.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5348618
• MDR Text Key: 35620448
• Report Number: 3005462046-2015-00038
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2017
• Device Model Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device Lot Number: F14100023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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