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

Catalog Number	TSFBP-35-145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: d2b: dqx.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, during an angiogram the bentson plus fixed core wire guide separated.According to the initial reporter, access was gained using an unspecified 19-gauge needle and the complaint device was advanced through the needle without issue.Upon removing the needle, another manufacturer's sheath was placed over the bentson plus fixed core wire guide.The wire guide was then removed from the sheath and the reporter noticed there was a separation in the wire.It was stated that there was no resistance during the removal of the wire.The reporter stated the details of the patent's anatomy and whether or not there was any calcifications of the vessel is unknown.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.
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
A review of the complaint history, device history record, documentation, manufactures instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used tsfbp-35-145 bentson plus fixed core wire guide was returned.Upon further inspection it was noted that the wire was not separated as initially reported.The distal portion of the device was bent.A section of elongated coil was noted 11.1cm from the distal tip.The weld ball of the distal tip was intact.The wire was 147.2cm in length and had a.0341 cm diameter.The device analysis did not verify the initial report of the wire being separated as the measured length and presence of the distal weld ball confirmed the device was intact.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 contribute to this failure mode.The first nonconformance was for stretched coil, and the second was for an offset coil.While one of these is related to the reported failure mode, it should be noted that all affected units were scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation was unable to establish a definitive cause.The reported failure could not be verified, so the complaint will be confirmed based on the unraveling coil noted near the distal end, not separation.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: BENTSON PLUS 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: 8063623
• Report Number: 1820334-2018-03224
• Device Sequence Number: 1693766
• Product Code: DQX
• UDI-Device Identifier: 00827002097353
• UDI-Public: (01)00827002097353(17)230828(10)9080823
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 08/28/2023
• Device Catalogue Number: TSFBP-35-145
• Device Lot Number: 9080823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: 6 FR X 25 CM TERUMO SHEATH