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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported when the physician was advancing the micropuncture transitionless access set dilator over the wire, the dilator hub snapped and the top of the dilator was twisted.A section of the device did not remain inside the patient铠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.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the device was received in a used and damaged condition.The inner dilator was inserted into the outer sheath, but the two were not locked together as received.The dilator was removed for examination, and was noted to be tight and difficult to remove.This is most likely due to the bend in the shaft of the device.The inner dilator's hub was twisted with respect to the shaft and was attached to the shaft.There was a kink noted at the connection to the hub and also at 0.8 cm distal to the hub.The dilator retained the bend noted in the catheter shaft when it was removed.While the hub had not completely separated, it was very loosely attached to the dilator shaft.The snap that the customer reported may have been related to the weakening of the shaft at this location.When the dilator was removed for examination, we did not pull on the hub to avoid damaging the returned device, rather we pulled on the shaft to remove it.Upon removal, the looseness that was noted was due to the damage to the shaft at 0.8cm distal to the hub.The hub and shaft were securely attached.The outer sheath was also bent.There was a kink in the sheath noted at 0.3cm distal to the hub.Also there were crimp marks in the shaft at 2.3, 2.8 and 3.3 cm distal to the hub which may have resulted from an instrument used to remove the device.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on review of the complaint device and the noted bends, kinks and twists in the component parts, it is reasonable to conclude that the device was exposed to high forces during use.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported when the physician was advancing the micropuncture transitionless access set dilator over the wire, the dilator hub snapped and the top of the dilator was twisted.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.

• 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: 5900468
• Report Number: 1820334-2016-00836
• Device Sequence Number: 815078
• Product Code: DYB
• UDI-Device Identifier: 00827002479500
• UDI-Public: (01)00827002479500(17)190405(10)6868493
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2016

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 Model Number: N/A
• Device Catalogue Number: MPIS-405-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1