MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2001-2515

Device Problems Break (1069); Fracture (1260); Sticking (1597); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

The angiosculpt device separated in the patient.Additional intervention was required to remove from the patient, thus resulting in prolongation of the case.The cath lab report and angiogram were received for evaluation.After review of the case, it appears that there is no angiographic evidence of a catheter part/piece, being left in the patient.Patient information regarding relevant test or laboratory data is unknown.This information was not available from the facility.Foreign- (b)(6).The angiosculpt device was returned with only the distal half that was intact to a 0.014" guide wire.The proximal half of the catheter was not returned.Visual examination found an elevated scoring element with what appears to be plaque stuck at the distal section.Two scoring element rings were lifted and the distal bond was damaged with bare spots exposing the scoring element rings.The rx port was lacerated and the shaft was severely stretched and separated at the hypotube.During withdrawal, the angiosculpt device got stuck in the lesion.Based on the lab analysis, excessive exertion of force was applied which caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

A 2.5 mm angiosculpt was used for a pre-dilatation in the lad.Upon removal, it got stuck in the proximal lad while pulling back into the guiding catheter.The shaft of the angiosculpt fractured after trying to remove it with force.A second wire and a trapping balloon were used to remove the broken part out of the patient.A stent was placed in the lad to complete the procedure.No patient injury or complication, however the patient was admitted 1 night for observation.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 6526602
• MDR Text Key: 73862691
• Report Number: 3005462046-2017-00006
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P050018
• 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
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2019
• Device Model Number: 2001-2515
• Device Catalogue Number: 2001-2515
• Device Lot Number: F16040054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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
• Treatment: ABBOTT- 0.014" GUIDE WIRE; CORDIS- 7F INTRODUCER SHEATH; MEDTRONIC- 7F GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76