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

Model Number	N/A
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that an cook amplatz extra-stiff support wire guide was being used in conjunction with a zilver ptx 35 drug-eluting stent (another manufacturer) during a right-leg angiogram when the two devices malfunctioned.It was reported that after deploying one stent in the patient's sfa another stent of the same kind was placed.However, the zilver ptx deployment system of the second stent became "caught" on the wire guide as it was being removed.In order to remove the deployment device, the wire guide had to be removed alongside the zilver ptx deployment system.A new amplatz extra-stiff support wire guide was inserted and a "mustang balloon" was used to post-dilate the second zilver ptx 35 drug-eluting stent.Soon after, it was observed that a clot had developed in the proximal stent and tpa was administered.Using an "angiodynamics unifuse catheter system," followed by the use of an "angio jet machine" in the proximal stent.Allegedly, the clot then migrated through both stents, to the patient's trifurcation.In addition, it was reported that thrombus was also seen in the popliteal vessel, and the patient underwent a femoral-popliteal bypass surgery soon after.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, and quality control data, and visual inspection and dimensional verification of the returned product and of an unused product were conducted during the investigation.Complainant device measurements were taken prior to shipment of the amplatz wire used device.The results showed, length= 260cm and od of the wire =.035 inches which meet specifications.Visual examination showed kinks at 57cm, 78.5cm, 80.5cm and 87cm from the proximal end.A device bend was noted 12.5cm from distal end.The wire was not broken and both welds were intact.No damage to the surface of the wire was noted.Also, one unused (sealed) amplatz extra-stiff support wire guide was returned for investigation.Laboratory results showed the unused device met dimensional and physical requirements.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows 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 provided information, inspection of returned product and an used product, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.
Additional Manufacturer Narrative
One used amplatz extra-stiff support wire guide was returned to cook ireland intact for investigation.Engineers had to cut the distal inner component of the delivery system in an attempt to remove the wire guide.Cutting the distal inner component also cut the wire guide resulting in two sections.Section one (distal end) is 170.3cm in length.Section two (proximal end) is 93.2cm in length.The welds on both ends are intact.Section one has a bend at 157.5cm from the proximal end.Section two has a bend at 35.0cm from the proximal end.A second bend is noted at 76.5cm from the proximal end.A third bend at 57.5cm, a fourth bend at 80.0cm,and a fifth bend at 90.0cm.There is no evidence the product was damaged upon opening.Prior to distribution, all amplatz extra-stiff support wire guides are subject to visual inspection and functional checks to ensure device integrity.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.

• Brand Name: AMPLATZ EXTRA-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: 6741175
• Report Number: 1820334-2017-02201
• Device Sequence Number: 11074349
• Product Code: DXQ
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)211208(10)7455253
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-260-AES
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/14/2017; 08/28/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/16/2017; 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 DA
• Patient Weight: 95