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

Catalog Number	HMW-14-300-ST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a peripheral angiogram, while passing the approach hydro st microwire wire guide past a lesion in the tibial artery, the wire tip broke off inside of the patient.The broken tip remained in the cxi catheter being utilized; both were able to be easily removed as a unit.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, specifications, trends, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of two kinks at distances of 139.5 cm and 264.5 cm from the proximal end.It was also noted that 7 mm of coil was missing, which exposed the core wire at the distal end.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.It is possible, however, that user technique contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 7083452
• Report Number: 1820334-2017-04347
• Device Sequence Number: 864669
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)200423(10)8165196
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K091385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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 Catalogue Number: HMW-14-300-ST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 70