MAUDE Adverse Event Report: COOK INC PERFORMER HAUSDORF-LOCK GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G28434
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure to treat an atrial septal defect involving a male patient "in his thirties" with a history of (b)(6), a performer hausdorf-lock guiding sheath leaked at the hemostatic/check-flo valve.An unknown sizing balloon and an unknown manufacturer's amplatzer septal occluder were used during the procedure.The complaint device was inserted from the right femoral artery; using the dilator and unknown wire guide.After the wire guide and dilator were removed, blood leakage was observed from the valve.There was nothing inside the sheath at the time leakage occurred.The sheath was removed and another 11 french sheath was used.The amplatzer device was placed and the procedure was completed.The patient did not require a blood transfusion as a result of the leak.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the device history record, complaint history, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A 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.Furthermore, a review of the quality control procedures was conducted, and no gaps were discovered.The device is accompanied by instructions for use (ifu), which caution, ¿the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight." based on the information provided and no product returned, investigation has concluded that no cause could be established for the device failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: PERFORMER HAUSDORF-LOCK GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8816409
• Report Number: 1820334-2019-01762
• Device Sequence Number: 3205636
• Product Code: DYB
• UDI-Device Identifier: 00827002284340
• UDI-Public: (01)00827002284340(17)190802(10)7166076
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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 Expiration Date: 08/02/2019
• Device Model Number: G28434
• Device Catalogue Number: RCFW-12.0-38-75-RB-HLA-091100
• Device Lot Number: 7166076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1