MAUDE Adverse Event Report: COOK INC FLEXOR RAABE GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G11635
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, while prepping the flexor raabe guiding sheath for a balloon dilation procedure in the pulmonary artery, the joint of the sheath near the white hub of the device separated.According to the initial reporter, the procedure was completed using new device of the same type.The device did not make patient contact.
Additional Manufacturer Narrative
Summary of event: it was reported, while prepping the flexor raabe guiding sheath for a balloon dilation procedure in the pulmonary artery, the joint of the sheath near the white hub of the device separated.According to the initial reporter, the procedure was completed using new device of the same type.The device did not make patient contact.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, specifications, and visual inspection and functional test of the complaint device was conducted during the investigation.The physical examination of the returned device confirmed hub separation.Biomatter was present on the device.The flare was found to be within specification.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, validations, and manufacturing documents provide evidence to suggest that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.No gaps have been found in the manufacturing and quality control process.The product ifu states: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the results of the investigation, cook has concluded that the cause for this event cannot be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9226782
• Report Number: 1820334-2019-02677
• Device Sequence Number: 2132137
• Product Code: DYB
• UDI-Device Identifier: 00827002116351
• UDI-Public: (01)00827002116351(17)220528(10)9767815
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 05/28/2022
• Device Model Number: G11635
• Device Catalogue Number: KCFW-7.0-38-70-RB-RAABE
• Device Lot Number: 9767815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 63