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

Catalog Number AI-07126

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in the cath lab, the wedge pressure catheter was pre-tested and it was noted at this time that it was difficult to inflate the balloon.Nevertheless, the wedge pressure catheter was inserted into the patient.They had trouble bringing the balloon back down after it was deployed in the patient.The balloon deflated after using a much larger syringe.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was no reported delay or interruption.The patient outcome is ok.

Manufacturer Narrative

(b)(4).Evaluation: no product was returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the balloon would not deflate is not able to be confirmed.The root cause of the complaint is undetermined.

Event Description

It was reported that while in the cath lab the wedge pressure catheter was pre-tested and it was noted at this time that it was difficult to inflate the balloon.Nevertheless, the wedge pressure catheter was inserted into the patient.They had trouble bringing the balloon back down after it was deployed in the patient.The balloon deflated after using a much larger syringe.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.There was no reported delay or interruption.The patient outcome is ok.

• 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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5172141
• MDR Text Key: 29204803
• Report Number: 3010532612-2015-00027
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F15H0101
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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