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

Catalog Number OL-XA25455

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Date of birth - 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 -unknown due to unknown lot number combination.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the shipping inspection record.Ifu states: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.Continuing to manipulate the guide wire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and /or endo therapy accessory.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.However, based on the reproductive tests previously conducted, the guide wire may become fractured when it has been subjected to force.(b)(4).

Event Description

The user facility reported that during ercp (endoscopic retrograde cholangiopancreatography), the user was using the actual sample in the pancreatic duct in the pancreas head.When the actual sample was pulled to the papillary side, it was noticed fluoroscopically that a few millimeters of the actual sample had become fractured and remained in the pancreas.It was reported that the user has never tried to retrieve the fractured piece and it is still in the patient's body.The procedure outcome is unknown.It was reported that the patient had recession of symptoms.

• 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: 7446834
• MDR Text Key: 106042711
• Report Number: 9681834-2018-00056
• 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: 04/20/2018

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: OL-XA25455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ANGIOGRAPHIC CATHETER (PR-110Q-1 OR MTW)
• Patient Outcome(s): Other
• Patient Age: 77 YR