MAUDE Adverse Event Report: COOK INC AMPLATZ STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G27032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a patient of unknown gender or age was undergoing placement of a right femoral vein catheter for hemodialysis using an amplatz stiff support wire guide.During insertion of the dialysis catheter, the amplatz stiff support wire guide fractured.It had not been altered from it's original state.The physician felt the wire separate when attempting to remove the wire.Reportedly, there was possible kinking of the wire while inserting the dialysis catheter over it.The patient's anatomy was unremarkable.The physician was able to remove the fractured piece within the dialysis catheter and remove everything from the patient with difficulty.Other devices used were a 16fr peel away sheath (manufacturer unknown).A portion of the wire did not remain in the patient's anatomy.No patient adverse effects have been reported.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, drawing, manufacturer¿s instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used separated amplatz stiff support wire guide was returned for investigation.The device was separated into three segments with varying degrees of damage (bends & biomatter).The first segment was 101.1cm in length, with the weld ball at the proximal end intact.The proximal end of the wire was peeling, likely due to handling.The mandril was bent and exposed at the distal end of the first segment.The second segment was 27cm in length.The mandril was curved and exposed the proximal and distal end of the segment.The mandril itself measured 5.5cm and the coil was extended to 21.5cm.The coil was separated and elongated near the distal end.As for the third segment, it measured 39.8cm in length and the tip was intact and undamaged.The coil was curved and separated near the proximal 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 two nonconforming events which could potentially contribute to this failure mode.These non-conformities were for an extended coil and a broken wire.While these could potentially be related to the reported failure mode, it should be noted that all affected units were scrapped and not replace.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that its possible that this event could be related to damaging the device.Reportedly, during the insertion of the catheter the physician stated that kinking may have occurred during the advancement of the catheter over the wire.However, without more information, cook is unable to confirm this potential cause.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: AMPLATZ STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8571806
• Report Number: 1820334-2019-01023
• Device Sequence Number: 1809578
• Product Code: DQX
• UDI-Device Identifier: 00827002270329
• UDI-Public: (01)00827002270329(17)240222(10)9502555
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 02/22/2024
• Device Model Number: G27032
• Device Catalogue Number: THSF-35-145-ASG
• Device Lot Number: 9502555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 16FR X 50CM DIALYSIS CATHETER(DECATHLON).