MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G49933

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient had cystoscopy to remove device fragments.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, a urologist was inserting a suprapubic malecot (percutaneously) in an older teenage male patient (age unknown).An ¿angiocath¿ (needle) was used to insert a standard fixed core wire guide.The malecot catheter was placed over the wire and when they went to pull the wire, it seemed stuck.A small incision was made to get the wire out.The wire came out in multiple pieces.A cystoscopy was performed and the surgeon confirmed all the pieces were retrieved and the patient is fine.No additional patient consequences were reported.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Additional information: the event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: section c.Investigation ¿ evaluation.It was reported, a urologist was inserting a universa malecot suprapubic percutaneous drainage catheter into the patient.An ¿angiocath¿ (15g locking needle from the universa malecot suprapubic percutaneous drainage catheter kit) was used to insert a standard fixed core wire guide.The malecot catheter was placed over the wire and when they went to pull the wire, it seemed stuck.A small incision was made to get the wire out (the suprapubic insertion site was enlarged).The wire came out in multiple pieces.A cystoscopy was performed, and the surgeon confirmed all the pieces were retrieved and ultimately the clinical outcome from the surgery was good.There were no additional consequences to the patient as a result of this occurrence.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.One ptfe wire guide was returned for investigation.The physical/visual examination of the returned device showed: the wire guide was returned in four (4) separate pieces/sections.Both of the ball welds were present.As a result of the wire guide separation, the mandril and safety wire were both exposed throughout each section and each section had elongation.The wire guide outside diameter (od) measured 0.035¿ which is within device specification.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The wire guide is not supplied with an instructions for use (ifu).Cook has concluded that the main cause of the failure is due to component failure unrelated to manufacturing or design deficiencies.The risk analysis for this failure mode was reviewed, and it was determined that no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10065185
• MDR Text Key: 191253636
• Report Number: 1820334-2020-00959
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002499331
• UDI-Public: (01)00827002499331(17)220313(10)9588737
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

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 Expiration Date: 03/13/2022
• Device Model Number: G49933
• Device Catalogue Number: 635413
• Device Lot Number: 9588737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 08/21/2020
• Supplement Dates FDA Received: 05/20/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 89