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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during an anterior tibial balloon procedure, of the anterior tibial, pedal access was used and when the sheath was pulled it was noted 2.5 cm of the sheath had broken off.Reportedly the physician was considering irrigation and drainage (i&d) to remove the fragment, however i&d was not done because the patient may need to have an amputation due to arterial issues and i&d would not be necessary as of the date of this report the patient outcome and if the sheath fragment has been removed are unknown.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.The customer returned one used and separated portion of a ptwt-4.0-42-10 outer sheath from the mpis-401-pedal-nt-u-sst set.The complaint device as returned was securely attached at the hub to shaft connection.The shaft shows complete separation with some indication of stretching 4.2 cm from the proximal hub.There was also a slight bend at 2.0 cm from the hub.The distal portion of the shaft was not returned as the complaint file indicates that it remains in the patient.A document based investigation evaluation was 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 the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined; however, it is possible to suggest that the patient condition and anatomy may have contributed to this event.The physician noted that this intervention was attempted to try to cross an obstruction and open it to prevent an amputation.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 during an anterior tibial balloon procedure, of the anterior tibial, pedal access was used and when the sheath was pulled it was noted 2.5 cm of the sheath had broken off.Reportedly the physician was considering irrigation and drainage (i&d) to remove the fragment, however i&d was not done because the patient may need to have an amputation due to arterial issues and i&d would not be necessary.As of the date of this report the patient outcome and if the sheath fragment has been removed are unknown.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5946591
• Report Number: 1820334-2016-00970
• Device Sequence Number: 19043157
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)171121(10)5466387
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/18/2016
• 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: Other
• Patient Age: 81 DA
• Patient Weight: 101