MAUDE Adverse Event Report: COOK INC APPROACH HYDRO ST MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G52939
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Occupation = lead tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, at the end of a fistulogram, an advance 14 lp low profile balloon catheter became stuck on an approach hydro st microwire wire guide.Upon receipt of the complaint approach hydro st microwire wire guide, the device was noted to be separated.The (b)(6) male patient reportedly had a history of hypertension, diabetes, late-stage renal disease, and sleep apnea.At the end of the procedure, after deflation of the balloon, the device was removed from the patient.Once the device was removed from the body, the user reported that the balloon catheter had adhered to the cook approach hydro st microwire wire guide and the catheter was unable to be removed from the wire.As the user continued to attempt to remove the balloon catheter from the wire, the balloon portion separated from the catheter.This has been reported under report reference number 1820334-2019-01032.The separation occurred outside the patient, and the procedure was successfully completed.The cook wire guide was reportedly not altered prior to the event.The wire's hydrophilic coating was activated using a "wet bowl" and was thought to be activated throughout the procedure.It is unknown how long the hydrophilic coating was activated or how many times the wire was used during the procedure, although the wire was reportedly in the patient for no longer than five minutes.The physician used powdered gloves.There was no flaking of the wire observed.An unknown sheath was used during the procedure.A cook inflation device was used to inflate the balloon, however details regarding inflation(s) are unknown.The balloon was not removed through the sheath.The separation of the wire guide was not reported by the user, but was found by investigators upon return of the device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, quality control procedures, and specifications of the returned device were conducted during the investigation.An evaluation of the returned device was performed by the supplier.The supplier investigation did not find any related non-conformances.The supplier stated that the separated section of the device that is hydrophilically coated was not returned.They were therefore unable to determine if hydrophilic coating was present.The returned device portion was broken at approximately 1010mm from the proximal end.There was a kink noted at 5mm from the break site.The supplier investigation concluded that the cause of the separation was most likely excessive handling after the procedure.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the supplier¿s examination of the returned product, investigation has concluded that the device failure was most likely a result of handling damage while the user was attempting to remove the wire from the catheter outside the patient.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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: APPROACH HYDRO ST MICROWIRE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8583701
• Report Number: 1820334-2019-01132
• Device Sequence Number: 11258117
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)201007(10)8650772
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 8650772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR