MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE TUNNELER; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number TUN60850J

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.Examination of the returned device revealed the following: the handle was confirmed to be a gore® tunneler product.It cannot be confirmed that the sheath and tip are gore® tunneler products.The examination found no anomalies attributable to the manufacture of the gore® tunneler handle.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore: on (b)(6) 2017, a gore® tunneler was used in a femoral-popliteal artery bypass procedure.During the procedure, the bullet-tip detached from the rod inside the patient.The tip was removed without incident during the procedure.The physician suspected that the rod was longer than usual.

Manufacturer Narrative

Additional manufacturer narrative: gore was notified the tip of the device was removed surgically.Therefore, is being changed to serious injury.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer.

Manufacturer Narrative

Device evaluation - examination of the returned device revealed the following: the finish on the handle was frosted; the finish on the sheath was polished; when the sheath was put on the handle, the sheath did not fit flush against the handle; without the sheath, it took approximately 11.5 turns to tighten the tip; with the sheath, it took approximately 1.5 turns to tighten the tip; the handle was confirmed to be a gore® tunneler product.It could not be confirmed that the sheath and tip were the same generation gore® tunneler, or even a gore® tunneler product.The examination found no anomalies attributable to the manufacture of the gore® tunneler handle.

• Brand Name: GORE TUNNELER
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6647566
• MDR Text Key: 78024777
• Report Number: 2017233-2017-00306
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K844584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2017

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 Catalogue Number: TUN60850J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2017; 09/05/2017; 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR