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

Catalog Number	MPIS-405-SST
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during the procedure, the micropuncture transitionless access set dilator stretched as it was withdrawn from the patient's groin.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, specifications, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.One used micropuncture transitionless access set was returned for evaluation.The sheath and dilator lengths were examined, as well as the connection of the sheath and dilator to their respective hubs.The sheath length met requirement, while the dilator was elongated.A one (1) millimeter (mm) compression in the dilator was noted 6.3 centimeters (cm) from the proximal hub, and approximately 4 cm of elongation starting from the proximal end.Both the sheath and dilator were securely connected to their hubs, and a smooth transition between the sheath and dilator was noted.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Following production, the devices are 100% inspected for damage.Review of the device history record of the finished product shows three nonconforming events for device components that could contribute to this failure mode.The affected parts were reworked prior to completion of the work order.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 7114638
• Report Number: 1820334-2017-04349
• Device Sequence Number: 11236558
• Product Code: DYB
• UDI-Device Identifier: 00827002479500
• UDI-Public: (01)00827002479500(17)200628(10)8027025
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-405-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1