MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-3015

Device Problems Deflation Problem (1149); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Foreign- canada.The angiosculpt device was not returned by the facility, thus no returned product investigation was performed.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

The angiosculpt catheter was used in the coronary artery to treat the lad and diagonal branch.The catheter was advanced over a non-manufacturer¿s guide wire with no issues reported.Post angioplasty, the catheter became entangled with the guide wire; therefore, was removed as a unit.Upon removal, the balloon appeared to be half-deployed and did not rewrap fully to its original position, which likely caused the entanglement.The lesion was rewired and completed the procedure with a non-angiosculpt balloon.No patient injury reported.This adverse event and product problem is being reported due to the balloon unable to fully deflate and placement of a new guidewire was necessary to complete the procedure.

Manufacturer Narrative

Block d4: the unique identifier (udi#) was corrected from (b)(4) to (b)(4).Blocks h3/h6: the angiosculpt device was lost at the customer site, thus no returned product investigation was performed.In the initial mdr, type of investigation code #4114, investigation findings code #3221, and investigation conclusion codes #67 and #22 were listed and remains appropriate.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: ANGIOSCULPT RX PTCA
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 15047013
• MDR Text Key: 296132857
• Report Number: 3005462046-2022-00032
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021214
• UDI-Public: 00813132021214
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G22030024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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" BMW II GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 68 KG