MAUDE Adverse Event Report: COOK INC BIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number not provided.(b)(4).The event is currently under investigation.

Event Description

During a ureteroscopy procedure, the outer sheath of the wire guide separated within the patient and the fragments were successfully removed via instruments.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation.A review of the complaint history, device history record, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device reported approximately 4.7 cm section of the device jacket material was missing starting at approximately 36 cm from the distal tip of the device.It was confirmed that portions of the outer coating had been scraped off.This device is a purchased item, and the lot acceptance report from the vendor indicated that the lot passed quality controls with no issues.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode it is feasible to suggest that insufficient care was taken during the procedure to prevent damage to the coating by the device through which the wire guide was inserted.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.

Event Description

During a ureteroscopy procedure, the outer sheath of the wire guide separated within the patient and the fragments were successfully removed via instruments.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: BIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5564350
• MDR Text Key: 42224140
• Report Number: 1820334-2016-00213
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)181031(10)10593310
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: BWS-035150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2016
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 65