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	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that as the physician was withdrawing the dilator from the artery, the dilator stretched.It was also noted this happened previously but in that case, the dilator snapped.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.Review of the device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, no product returned, and the investigation, a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.
Event or Problem Description
It was reported that as the physician was withdrawing the dilator from the artery, the dilator stretched.No further information was provided regarding the patient outcome or the completion of the procedure.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One micropuncture transitionless access set was returned for investigation.The outer catheter and inner dilator were received in used condition.Compression marks were noted at 2 millimeters (mm), 3 mm, 6 mm, 13 mm, 15 mm, and 30 mm from the proximal end of the inner catheter.In the dilator's returned condition, the device length was out of specification.A document-based investigation was performed.Review of the device history record of the finished product (lot 7745376) shows no nonconforming events that could contribute to this failure mode; however, 14 non-conformances were identified for related lot 7623516 which were re-worked.A complaint history search revealed that there were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.There is no evidence that the product was damaged upon opening.Attempts were made to obtain additional information; however, no information was provided regarding the patient's pre-existing conditions or anatomic considerations relative to the case.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: 6731851
• Report Number: 1820334-2017-01801
• Device Sequence Number: 16349280
• Product Code: DYB
• UDI-Device Identifier: 00827002479500
• UDI-Public: (01)00827002479500(17)200313(10)7745376
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-405-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 11/13/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/05/2017; 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1