MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE

Catalog Number OL-XA35455

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Udi no: this product code is not required to be registered.The actual device was returned to the manufacturing facility for evaluation along with a competitor's catheter pr-v234q /(b)(4) olympus co., ltd.Visual inspection of the competitor's catheter found a guide wire segment trapped inside the catheter.The competitor's catheter was confirmed not to have any anomalies.The competitor's catheter was disassembled for further inspection.The guidewire segment was found to be seated around 50mm from the proximal end of the competitor's catheter deformed into a bent shape.The guidewire segment was taken out and found the distal end part to be fractured off the actual device.It was measured for the total length and found to be approximately 70mm.Magnifying and electron microscopic inspections of the fracture end of the guidewire segment revealed that the urethane outer layer presented the damage implying that it had been ripped off.No other anomalies which could be a trigger of the occurrence of the fracture were noted.The urethane outer layer was dissolved and removed from the guidewire segment for further inspection of the core wire.Electron microscopic inspection of the fracture end of the core wire revealed that it had been bent toward the end of the fracture with the surface of the fracture cross-section in the rough state.The actual device was inspection with the naked eye as well as under magnification.It was found that the distal segment had been fractured with the exposure of the core wire at the fracture end.Some abrasions were found on the segment around the fracture.Electron microscopic inspection of the fracture end of the core wire revealed that it had been bent toward the end of the fracture with the surface of the fracture cross-section in the rough state.The outside diameter was measured on the undamaged segments and confirmed to meet manufacturing specification.Simulated testing was conducted.The sample was subjected to a pulling force in the state of being formed into a loop shape until it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the distal end of the fracture had been curved with the surface of the fracture cross-section in the rough state.This state was found to be very similar to that of the actual device.The production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.There is no evidence that this event was related to a device defect or malfunction.While the exact cause cannot be definitively determined based on the available information it is likely the actual device was pushed forward and pulled back several times leading the distal segment to form into a loop shape.In that state the actual sample was subjected to a pulling force resulting in the reported fracture.The potential for such an event is addressed in the instruction-for-use (ifu) with statements such as the following: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endo therapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory." (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a fracture on the involved device.Follow up communication with the user facility confirmed the following information: prior to being used, during inspection the guidewire became fractured; and the device was not used on the patient.

• Brand Name: SINGLE USE GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6678662
• MDR Text Key: 78958880
• Report Number: 9681834-2017-00129
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA35455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Date Manufacturer Received: 06/05/2017
• 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: Initial
• Patient Sequence Number: 1