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

Model Number G30474

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: surgery materials coordinator.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a hiwire nitinol hydrophilic wire guide was pulled for an unspecified procedure.Prior to opening the package, they discovered there was a hair in the sealed package.The package was not opened and the device was not used.The procedure was successfully completed with another device of the same type.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, a hiwire nitinol hydrophilic wire guide was pulled for an unspecified procedure.Prior to opening the package, they discovered there was a hair in the sealed package.The package was not opened and the device was not used.The procedure was successfully completed with another device of the same type.Investigation ¿ evaluation.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, manufacturing instructions, and quality control data.The complainant returned one unopened hiwire nitinol hydrophilic wire guide to cook inc for investigation.A visual inspection observed a black fiber sealed in the package.A review of the device history record found no non-conformances related to the reported failure mode.Because there are 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 instructions for use (ifu), provides no information for end users related to this failure mode.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint was confirmed based on the returned device which contained a a 3.5 to 4cm hair-like matter sealed within the pouch adjacent to the left side seal midway along the left side of the pouch.Except where noted, the specimen device appeared visually and dimensionally correct.A supplier investigation found the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.Also the supplier has a 100% visual inspection in place to check for foreign matter.Cook has concluded the complaint was likely contributed to by handling factors at the supplier.The supplier has a site-wide corrective and preventative action project to address the issue of contamination and foreign material within pouches.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database 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.

Event Description

No new patient or event information to report.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11935058
• MDR Text Key: 255486498
• Report Number: 1820334-2021-01456
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)231013(10)71001010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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 Expiration Date: 10/13/2023
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71001010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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