MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number 1009661

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to position or guide wire separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in an av fistula.A high torque balance middleweight (bmw) universal guide wire was selected for the procedure.The bmw guide wire was advanced to the lesion and crossed.An unspecified balloon catheter was advanced with resistance over the bmw guide wire and the guide wire separated.The proximal portion of the bmw guide wire was removed from the anatomy with no issues reported.Cut down surgery was necessary to retrieve the distal portion of the bmw guide wire.The procedure was abandoned at that point.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: device catalog # and udi #.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficult to position or guide wire separation.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial filed medwatch report, a user facility medwatch report was received which stated: the separation of the hi-torque (ht) balance middleweight (bmw) universal guide wire with surgical intervention to remove the wire piece reportedly caused additional time in the hospital for the patient.No additional information was provided.User facility medwatch report states: during cath lab procedure guide with sheared and the patient had to go the cvor to have a portion of the wire removed.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6227618
• MDR Text Key: 64011659
• Report Number: 2024168-2017-00149
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(17)180228(10)6030171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1009661
• Device Lot Number: 6030171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 117