MAUDE Adverse Event Report: COOK INC COPE MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 510k status: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The customer reported that, during a right femoral access procedure, resistance was felt when the cope mandril wire guide was inserted and advanced into the needle.The wire then began to separate while it was being removed back out through the needle.An new wire was then used without further issues.No patient adverse events were reported, and no additional procedures were necessitated as a result of the issue.The device has been returned for evaluation however, as of the date of this report, the device investigation is still pending.

Manufacturer Narrative

Additional information: gender: female.Date of event: (b)(6) 2018.The procedure being performed was an antegrade left leg angioplasty and laser atherectomy.No pre-existing condition or pre-diagnosis relevant to this event.Concomitant medical products: mpis-501-nt-sst set.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification of the returned device were conducted during the investigation.One used and damaged pmg-18sp-60-cope guide was returned for investigation.The distal and proximal solder joints were intact, and the mandril was separated 1.7cm from the distal end.The coils connecting the pieces were elongated it is likely that the elongation of the coils was a result of removing the guide after the mandril wire separation, and that the mandril separation occurred due to removal from the needle.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.Affixed to the wire guide protective shipping tube is a caution label (l_scor_rev.0) that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.We can also advise that manipulation of the wire through the needle may cause damage to the coil.Based on the information provided, the examination of the returned product, and the results of our investigation, the likely root cause was determined to be user technique.It was stated by the customer that the wire guide was withdrawn from the needle, and there is a label fixed to the wire guide holder that states that the wire guide should not be withdrawn from the needle.The investigation findings are to be sent to the customer.We will continue to monitor for similar complaints and notify appropriate personnel.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7338386
• MDR Text Key: 102859289
• Report Number: 1820334-2018-00709
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)220822(10)8114782
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18SP-60-COPE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MPIS-501-NT-SST SET