MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter customer name and address= phone: (b)(6).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 an unspecified procedure, an advance 35 lp low profile balloon catheter ruptured upon the first inflation.Access was obtained from the jugular vein to target the portal vein.The device was inflated one time, using an unknown inflation device, to six atmospheres when the balloon ruptured.A cook 10french sheath was in place; however, the ruptured balloon was removed by itself, not with the sheath.Another device of the same type but different size was then used to complete the procedure.There were no adverse effects to the patient.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an unspecified procedure, an advance 35 lp low profile balloon catheter ruptured upon the first inflation.Access was obtained from the jugular vein to target the portal vein.The device was inflated one time, using an unknown inflation device, to six atmospheres when the balloon ruptured.A cook 10french sheath was in place; however, the ruptured balloon was removed by itself, not with the sheath.Another device of the same type but different size was then used to complete the procedure.There were no adverse effects to the patient.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, quality control data, and specifications.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 made out of specification.A review of the device history record found no non-conformances related to the reported failure mode for the lot.No other lot related complaints have been received from the field.There is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) warns ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the ifu instructs the user to inspect the device upon removal from the package.Based on the available information, cook concluded the cause of this failure to be related to a manufacturing and quality control deficiency.The complaint device was manufactured prior to the implementation of a now closed capa investigation into this failure mode and potential causes.Corrective actions have since been implemented to address manufacturing- and quality control-related root causes for this failure mode.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11884339
• Report Number: 1820334-2021-01398
• Device Sequence Number: 19639158
• Product Code: DQY
• UDI-Device Identifier: 10827002523453
• UDI-Public: (01)10827002523453(17)211113(10)9307057
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/29/2021

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: 11/13/2021
• Device Model Number: G52345
• Device Catalogue Number: PTA5-35-80-6-4.0
• Device Lot Number: 9307057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1