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

Model Number	G52273
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer name and address- phone: (b)(6), postal code: 110076.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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
As reported, during a peripheral angioplasty, an advance 35 lp low profile balloon catheter ruptured.Another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional event details have been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction- the summary report designation is incorrect; the report is not a summary report.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Correction- the summary report designation is incorrect; the report is not a summary report.Event summary: cook was informed of an incident involving an advance 35 lp low profile balloon catheter.The balloon reportedly burst during the peripheral angioplasty procedure.The user discarded the balloon and used another balloon to complete the procedure.There have been no adverse effects to the patient as a result of this incident.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, drawing, manufacturing instructions, quality control data, specifications, and the instructions for use (ifu).The complainant did not return the complaint device for investigation, nor were photos of the device provided.There are no devices from the complaint device lot to be used for review.A document-based investigation evaluation was performed.No related non-conformances were recorded, and no additional lot-related complaints were received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿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.¿ ¿do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur.¿ instructions for use: balloon preparation: ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation: ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ how supplied: ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded a definitive conclusion could not be determined.The information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: 11392425
• Report Number: 1820334-2021-00860
• Device Sequence Number: 3256204
• Product Code: DQY
• UDI-Device Identifier: 10827002522739
• UDI-Public: (01)10827002522739(17)220517(10)9747576
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2021

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: 05/17/2022
• Device Model Number: G52273
• Device Catalogue Number: PTA5-35-135-7-6.0
• Device Lot Number: 9747576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2021
• Supplement Date Received by Manufacturer: 04/05/2021; 05/05/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR