MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a performer mullins guiding sheath was used in a procedure to correct coarctation of the aorta.During the procedure the handle of the dilator, the inner part of the sheath broke.The reported device that was being utilized through the sheath was a pavti-edwards sapien.Separation occurred during insertion into the patient's leg.The patient's anatomy was neither tortuous or calcified.A section of the device did not remain inside the patient's body and the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: further information was provided that the ¿connection was damaged.¿ investigation - evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control data, and visual inspection of the returned device was conducted during the investigation.The coaxial dilator was returned and visual inspection was completed.Check-in photographs show the inner dilator extending out of the distal end of the outer dilator.The proximal hub is attached, but appears damaged.There did not appear to be a separated, broken, or missing "handle" (proximal fitting/shrink tube).The proximal fitting for the coaxial dilator did appear to be damaged on the inner edge.It is feasible to suggest that the observed damage occurred during use.Review of the 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 device evaluation and provided information, a definitive root cause cannot be determined at this time.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6633286
• Report Number: 1820334-2017-01369
• Device Sequence Number: 14368
• Product Code: DYB
• UDI-Device Identifier: 00827002127821
• UDI-Public: (01)00827002127821(17)200227(10)NS7707959
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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 Model Number: N/A
• Device Catalogue Number: RCFW-16.0P-38-85-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/08/2017
• Patient Sequence Number: 1