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

Model Number 2249-50200

Device Problems Separation Failure (2547); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

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

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

The patient's dob or age at time of event, gender, and weight are unknown.This information was not available from the facility.Lab analysis confirmed an overflow lifting of material at the distal bond 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 or laboratory data is unknown.This information was not available from the facility.(b)(4).The angiosculpt was returned for evaluation.Visual examination found a damaged scoring element with all struts bent and lifted from the distal bond with a slight lifting of overflow material.The intermediate bond was pulled distally and positioned over the balloon.The proximal marker band was located under the transition tubing.All pieces of the angiosculpt remained intact.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

Utilized a 5.0x200 angiosculpt in a calcified sfa post atherectomy (hawk one).The physician did one inflation then pulled negative and started to pull back when balloon was deflated and resistance was felt.The physician pulled balloon out of body and the scoring element was pulled up around the distal tip of the angiosculpt but did not detach.Note: lab analysis confirmed an overflow lifting of material at the distal bond.

Manufacturer Narrative

The patient codes and device codes 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: 5759907
• MDR Text Key: 49237643
• Report Number: 3005462046-2016-00017
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2018
• Device Model Number: 2249-50200
• Device Catalogue Number: 2249-50200
• Device Lot Number: G16030043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• 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
• Patient Outcome(s): Other