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

Model Number	G11635
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.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 pulmonary artery balloon dilation procedure involving a (b)(6) year-old male patient weighing (b)(6) kilograms with a history of pulmonary arterial hypertension, the hub of a flexor raabe guiding sheath separated from the device.The separation reportedly occurred after the sheath was partially inserted into the patient.The patient's anatomy was not reported to be tortuous or calcified.Another (unknown) device was used to complete the procedure successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that 7fr flexor raabe guiding sheath was returned to cook for investigation.The hub was returned detached from the sheath with the dilator inserted.Biomatter was noted throughout the device, and the flare was slightly stretched on one side.No other damage was noted to the device.Additionally, 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 did show one nonconforming event which could contribute to this failure mode.This nonconformance was for a failed leak test, but the effected unit was scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the examination of the returned product, investigation has concluded that a root cause could not be established.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.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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 new patient or event information since the last report was submitted.

• 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: 8716534
• Report Number: 1820334-2019-01487
• Device Sequence Number: 2091428
• Product Code: DYB
• UDI-Device Identifier: 00827002116351
• UDI-Public: (01)00827002116351(17)220123(10)9467630
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2020

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: 01/23/2022
• Device Model Number: G11635
• Device Catalogue Number: KCFW-7.0-38-70-RB-RAABE
• Device Lot Number: 9467630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 03/18/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/22/2019; 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 60