MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; BALLOON WEDGE PRESSURE CATHETER

Catalog Number AI-07126

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab the wedge pressure was inserted via the patient's femoral artery.While in use the balloon ruptured.On (b)(6) 2016 additional information received.The wedge pressure was pretested one time using the controlled stroke syringe.The wedge pressure catheter was inflated twice in use before rupturing.Carbon dioxide (co2) was used for inflation.There was no reported patient death or complications from the procedure.

Manufacturer Narrative

(b)(4).Additional information - uf reporter # (b)(4).On 09/27/2016 a medwatch report was received.Event desc: inserted catheter into patients pulmonary artery and filled balloon in catheter tip with co2.Balloon tip popped due to heavy calcification in the blood vessel.Removed catheter and inserted balloon tip catheter was not defective; it burst due to calcification in the patient artery.Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.Evaluation: the sample was returned with the supplied return kit and was in a sealed bio-hazard bag.Upon return, blood was noted on the exterior surfaces of the catheter and on the interior of the injection lumen.The recommended volume capacity of the balloon is 1.0cc.The balloon was noted ruptured at the distal tip and the event details state that the damage was due to the condition of the blood vessel.It is unknown if any fragments of the balloon were retained.The 1.0cc control stroke syringe typically supplied with the product was not returned.No other damage was noted.See other remarks section.Other remarks: the injection lumen was aspirated and flushed using a lab inventory syringe; blood exited upon performing.A lab inventory 0.025in guidewire was back loaded through the tip of the catheter.The guidewire was able to advance through the catheter.No blood or debris was noted upon removal.A device history record (dhr) review was conducted for the lot number given with the returned device.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the balloon ruptured is confirmed by visual inspection of the device.The event details state that the damage was not due to a product failure but was due to the condition of patients' blood vessel.It is unknown if any fragments of the balloon were retained.

Event Description

It was reported that while in the cath lab the wedge pressure was inserted via the patient's femoral artery.While in use the balloon ruptured.On 09/08/2016 additional information received.The wedge pressure was pretested one time using the controlled stroke syringe.The wedge pressure catheter was inflated twice in use before rupturing.Carbon dioxide (co2) was used for inflation.There was no reported patient death or complications from the procedure.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: BALLOON WEDGE PRESSURE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5953576
• MDR Text Key: 54886109
• Report Number: 3010532612-2016-00027
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F16F0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR