MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500

Device Problem Volume Accuracy Problem (1675)

Patient Problems Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device / parts will not be returned for evaluation.

Event Description

It was reported via a hot line call that the rn in the intensive care unit had received a patient from the cardiac cath lab and the augmentation was not optimal.The rn noted the iab volume was 2.5 and she had not seen that before.The rn stated the iab was not zeroed prior to insertion and wanted help calibrating the catheter.The clinical support specialist (css) instructed the rn to stop pumping, disconnect the iab from the pump and reconnect.The rn verified the iab volume was now reading 30cc.The rn then reinitiated pumping and stated the waveform looked better.The css then walked the rn through the calibration procedure and the rn confirmed the lightbulb changed to white (fiberoptix iab cal value manually adjusted) and the hemodynamics was appropriate.It was noted that the length of time in use prior to the event was less than one hour.

Manufacturer Narrative

(b)(4) evaluation: no intra-aortic balloon pump (iabp) parts or recorder strips were returned to teleflex (b)(4) facility for evaluation.Device history record review is not required.The pump functioned as designed.Conclusion: the reported complaint of "balloon volume incorrect" is confirmed based on the information provided to the css.The pump functioned as designed.This was a successful clinical call.No further action required.

Event Description

It was reported via a hot line call that the rn in the intensive care unit had received a patient from the cardiac cath lab and the augmentation was not optimal.The rn noted the iab volume was 2.5 and she had not seen that before.The rn stated the iab was not zeroed prior to insertion and wanted help calibrating the catheter.The clinical support specialist (css) instructed the rn to stop pumping, disconnect the iab from the pump and reconnect.The rn verified the iab volume was now reading 30cc.The rn then reinitiated pumping and stated the waveform looked better.The css then walked the rn through the calibration procedure and the rn confirmed the lightbulb changed to white (fiberoptix iab cal value manually adjusted) and the hemodynamics was appropriate.It was noted that the length of time in use prior to the event was less than one hour.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5261255
• MDR Text Key: 32512357
• Report Number: 1219856-2015-00264
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1