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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that while performing a melody valve procedure using a performer mullins guiding sheath, the hub of the dilator broke off.This happened twice in the same case.The first device broke when the scrub was assembling it.The second device broke when the physician was removing the sheath from the patient.This medwatch is for the second device.Please see medwatch with manufacture report number 1820334-2017-00956 for the first device.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One used performer mullins guiding sheath was checked in and examined.The dilator hub was separated from the shaft of the dilator.Slight compression mark is noted 2.5 cm from the distal tip of the dilator.A 1mm cut was noted on the distal tip.The sheath was examined and measuring from the proximal hub, kinks were noted at 8.9 cm, 25.5cm, 35.8cm and 42.1cm.The connector cap accepted a maximum pin gauge measuring 0.194".The flare was measured using calipers, the wider side measured 6.1mm and the narrow side 4.8mm, which sums up to an average of 5.45mm.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.Based on the available information and examination of the complaint device, the exact cause of the reported issue is unable to be determined.Per the quality engineering risk assessment, no further action is required.We have notified the appropriate personnel of this event and 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: 6562026
• Report Number: 1820334-2017-00957
• Device Sequence Number: 749661
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)191028(10)7399526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

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-14.0-38-75-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1