MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSFB-35-180
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.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
It was reported, a bentson straight fixed core wire guide was being utilized during an angioplasty procedure when, upon removal from the patient's anatomy through another manufacturer's sheath , it was noted to be bent or kinked with a hair-like piece of metal protruding about three inches from the end of the device.The customer reported this was as a result of a re-sheathing error which was described as a maneuver to re-form the tip making it stiff instead of floppy.The metal protrusion reportedly pierced the patient's vessel causing the contrast material to leak out the side into the tissue.No medical intervention was reported.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.According to the complainant, the complaint device will not be returned to the manufacturer for investigation.It was discarded at the facility.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: additional information was received from the customer.The customer elaborated on the manner in which the product was used.The operator inserted the wire inside the sheath, and pushed it though the vessel.Due to a tight stenosis, the wire did curve in the lesion several times.When the customer went to change out the product on account of the lack of desired access, the operator realized that the wire was bent, with a hair-like metallic wire sticking out of the product.The customer also confirmed that the wire was removed through a 6 french x 6 cm terumo sheath.Regarding the mitigation of the reported extravasation, a balloon dorado 8 x 40 mm was inflated in the area to contain the extravasation and to take care of the stenosis.The patency of the vessel was checked with injection of contrast.No contrast extravasation was visible and the caliber of the vessel was reestablished.No further care was done, except for the removing of the sheath and the holding of pressure on the vein.Investigation evaluation.A review of the complaint history, device history record, documentation, drawing, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows one nonconforming event which could contribute to this failure mode; however all nonconforming devices were scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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: BENTSON STRAIGHT FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7976603
• Report Number: 1820334-2018-03137
• Device Sequence Number: 13798332
• Product Code: DQX
• UDI-Device Identifier: 00827002012905
• UDI-Public: (01)00827002012905(17)230614(10)8919413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2023
• Device Catalogue Number: TSFB-35-180
• Device Lot Number: 8919413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: TERUMO SHEATH; TERUMO SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR