MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number OL-XA25455

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Lot number - unknown.Expiration date - unknown due to unknown lot number.Udi - the reported product is not required to be registered with the fda.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter unknown.Device manufacture date - unknown due to unknown lot number.The actual device was received for evaluation.Visual inspection upon receipt found that the urethane outer layer had come off the core wire on approx.35 mm - 40 mm from the distal end of the device.Magnifying and electron microscopic inspections obtained the findings as follows.The surface had been abraded and become rough on 0 - approx.50 mm from the distal end of the device.The urethane outer layer had been sheared in the distal direction and lifted from the core wire at approx.15 mm from the distal end of the device.The semicircular portion of the urethane outer layer had been removed and the gold coil was exposed on approx.35 mm - 40 mm from the distal end of the device.The end of the urethane outer layer at approx 35 mm from the distal end of the device had the configuration which implied that the urethane outer layer had been ripped off.The urethane outer layer had been deformed at approx.50 mm from the distal end of the device.The outside diameter was measured on the undamaged segment and confirmed to meet the specifications.The product lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint records.The labeling does address the potential for such an event 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 endotherapy 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 endotherapy accessory.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely that the actual device was manipulated in the state where its urethane outer layer had contact with a hard object, including bile duct calculus.As the result, the urethane outer layer got sheared, removed, deformed and abraded.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported an ercp (endoscopic retrograde cholangiopancreatography) was performed to remove calculi.The actual sample was inserted in to the bile duct.Several attempts to break through the calculi were not succeeded.Later, the customer found that the urethane coating had been sheared off the actual device.It is unknown if the sheared piece was left in the patient, or if they were aware of that being a possibility.Four (4) jagwires from boston were used with the product.The patient died of dehydration renal failure.The date of death is unknown.The death has nothing to do with this complaint.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 7345477
• MDR Text Key: 103160010
• Report Number: 9681834-2018-00028
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/16/2018
• 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