MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEX P3 F5 8X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.Please note that this is the first of two events reported by the same facility.The related manufacturing report is not available but will be supplied in the related report.

Event Description

During use of a 6x4 and a 9x4 (8x4)powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter, there was leakage.Only the 6x4 balloon will be returned for analysis.There was no patient injury.

Manufacturer Narrative

The device was returned and section d10 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.Please note that this is the first of two events reported by the same facility.The related manufacturing report is 9616099-2019-03035.

Manufacturer Narrative

Two non-sterile units of powerflex p3 f5 6x4 80 pta balloon catheters were received for analysis coiled inside a plastic bag.Units were identified as ¿unit 1¿ and ¿unit 2¿.However, only ¿unit 1¿ was analyzed under this complaint (analysis for ¿unit 2¿ is in a separated document).The balloon was received deflated.Per visual analysis, no anomalies were observed.Per current procedure, a lab sample syringe filled with water was attached to the luer hub of the catheter and successfully flushed.Neither resistance nor loosen material/ matter was observed during flushing procedure.Then, a.035¿ guide wire sample was successfully introduced into the guide wire lumen of the powerflex p3 balloon via tip all along through the unit.No obstruction was experienced during the insertion test.Finally, a three-way valve was attached to the inflation lumen port.Required pressure was applied to the device to inflate the balloon, a leakage was observed on the tip of the balloon while inflating the balloon (water coming out of the guidewire lumen on balloon area was observed).Bubbles were scaping the guidewire lumen near the proximal seal area.Per microscopical analysis, sem results showed that the guidewire lumen balloon leakage was caused by puncture holes on guidewire lumen.The inner surface of the balloon presented evidence of scratch marks and tears near to puncture holes and along the lumen, on the proximal seal area.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and tears on the guidewire lumen inner surface could probably led to the puncture holes condition found on the lumen.No other anomalies were found during the sem analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.The complaint reported by the customer as ¿balloon - leakage¿ was confirmed since balloon was inflated and a leakage was observed during functional test.However, the cause of the leakage could not be conclusively determined during the analysis.Neither the product analysis nor the sem analysis results suggest that the leakage condition could be related to the manufacturing process of the unit.Sem microscopic analysis results showed that the inner surface of the guidewire lumen presents evidence of scratch marks and tears.Therefore, it is assumed that a mechanical damage due to a sharp object caused the condition on the guidewire.No corrective action will be taken at this time since there are no indications that the reported complaint is related to the manufacturing process.Additional information is pending and will be submitted within 30 days upon receipt.Please note that this is the first of two events reported by the same facility.The related manufacturing report is 9616099-2019-03035.

Manufacturer Narrative

During use of a 6 x 4 and an 8 x4 powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter, there was leakage.There was no patient injury.Multiple attempts to obtain additional information were made without success.A non-sterile powerflex p3 f5 8 x 4 x 80 pta balloon catheter was returned (unit 1).The balloon was received deflated, no anomalies were observed.Functional analysis was performed, a lab sample syringe filled with water was attached to the luer hub of the catheter and successfully flushed.No resistance or loose material/matter was noted during flushing.An.035¿ guide wire sample was successfully introduced into the guide wire lumen via the tip all along the unit.No obstruction was noted.Finally, a three-way valve was attached to the inflation lumen port.Required pressure was applied for inflation, a leakage was observed on the tip of the balloon (water coming out of the guidewire lumen on balloon area was observed).Bubbles were escaping the guidewire lumen near the proximal seal area.Per sem analysis, the guidewire lumen balloon leakage was caused by puncture holes on the guidewire lumen.The inner surface of the balloon presented evidence of scratch marks and tears adjacent to the puncture holes and along the lumen, on the proximal seal area.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 82158490 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was confirmed through analysis of the returned device noted as unit 1.The exact cause of the leakage could not be determined.However, the ¿balloon leakage¿ complaint was not confirmed for unit 2 as there were no anomalies noted.Device analysis of unit 1 revealed the balloon¿s inner surface had evidence of scratch marks and tears adjacent to the puncture marks and along the guidewire lumen on the proximal seal of the balloon.This type of damage is commonly caused when balloon material encounters a sharp object or mechanical damage.Although unknown, it is likely that handling of the device contributed to the event reported.Unit 2 performed as intended and inflated without difficulty during functional analysis.According to the instructions for use, which is not intended as a mitigation of risk, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.¿ neither the phr review nor the product analysis of unit 1 suggests that the event experienced by the customer could be related to the manufacturing process.Without a lot number to conduct a phr review for unit 2, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.Please note that this is the first of two events reported by the same facility.The related manufacturing report is 9616099-2019-03035.

• Brand Name: POWERFLEX P3 F5 8X4 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 8722646
• MDR Text Key: 150853336
• Report Number: 9616099-2019-03034
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 4208040S
• Device Lot Number: 82158490
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1