MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Catalog Number	MPIS-502-NT-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a thrombectomy of a fistula, the wire of the micropuncture transitionless access set "fell apart" where it meets the floppy end.There was no calcification, scarring, tortuous anatomy nor was there angulation of the patient's anatomy reported.The separated device portion was snared and successfully removed from the patient's anatomy.The procedure was completed without any further issue.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
Investigation: evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a kink in the wire guide, which occurred a distance of approximately 7 mm from the distal tip.The weld ball was observed to be intact and centered at the distal end.The proximal end of the device appeared to be flattened and not round.Biomatter was present on the device.The mandril was not returned with the rest of the device.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.A failure related subassembly had two nonconformances which were related to the failure mode; however, these units were either reworked or scrapped and not replaced.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the 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: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7587905
• Report Number: 1820334-2018-01647
• Device Sequence Number: 19388456
• Product Code: DYB
• UDI-Device Identifier: 00827002562028
• UDI-Public: (01)00827002562028(17)210322(10)8687337
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/18/2018

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 Catalogue Number: MPIS-502-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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