MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE; HAP WIRE GUIDE

Model Number	G31453
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: wire guide broken during operation.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: the wire guide was returned inside the wire guide holder.The safety wire had fractured and consequently the coiled portion had severely elongated to 21,5cm - according to specifications it must be only 15cm.The safety wire exited from the coils and a microscopic investigation clearly revealed it was straightened prior to fractured.Calibrated tooling found the diameter of the safety wire was 0.1505, which is according to specifications, stating 0.15+/- 0.01.The safety wire had fractured next to the tip welding, but a remnant was noted inside the welding, thus indicating the welding of safety wire and coils being according to specifications.Only very limited information was provided and therefore the exact reason for the wire guide to fracture cannot be determined.However, it was reported that resistance was encountered during removal and said resistance combined with the investigation findings suggest the wire was exposed to manipulation beyond its intended design during the procedure.No evidence to suggest that this wire guide was not manufactured to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: HAP WIRE GUIDE
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7094761
• Report Number: 3002808486-2017-02353
• Device Sequence Number: 1495529
• Product Code: DQX
• UDI-Device Identifier: 00827002314535
• UDI-Public: (01)00827002314535(17)220912(10)E3627979
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G31453
• Device Catalogue Number: TSMG-35-260-LES
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/15/2017
• Device Age: 2 MO
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1