MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; INTRA-AORTIC BALLOON

Catalog Number IAB-S730C

Device Problem Aspiration Issue (2883)

Patient Problem Angina (1710)

Event Date 02/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that intra-aortic balloon pump (iabp) therapy was to be used for cardiac support.While in the intensive care unit and during insertion of the intra-aortic balloon (iab) via a sheath in the patient's right femoral artery, the clinician tried to aspirate blood from the central lumen of the catheter but failed.The iab was removed and another iab was not inserted.The patient was kept under close observation.There was a reported delay / interruption in iabp therapy however the timeframe is not available.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is stable.

Manufacturer Narrative

(b)(4).Additional information stated that the iab was prepped per the instructions for use prior to insertion.It is unknown if the patient had torturous vessels.The md reported that the patient was transferred to the cath lab for further treatment.Device evaluation: returned for evaluation was a 30cc 7.0fr iab.The one-way valve was connected to the inflation lumen.The catheter was returned with approximately half the bladder membrane withdrawn within the saf sheath.The proximal end of the sheath was located approximately 73.5cm from the luer end of the catheter.The catheter was returned with a spring wire guide (swg) fully inserted through the central lumen.Some dried blood was noted at the tip of the sheath.After removing the sheath from the catheter, dried blood was noted on the bladder membrane of the catheter.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The iab was submerged in water and leak tested.No holes or leaks were detected.Full inflation was achieved.The unit passed leak test.See other remarks section for continuation.Other remarks: the swg returned with the catheter was removed from the device.A kink was found on the swg approximately 70.0cm from the distal end.Some dried blood was noted on the swg after removal.The swg was able to be aspirated and flushed with air.A lab inventory swg was front loaded through the luer end of the iab.Some resistance was encountered approximately 16.0cm from the luer end.The swg was able to advance; no blood or debris exited with the swg.The swg was back loaded through the iab distal tip.Some resistance was noted approximately 70.0cm from the distal tip of the catheter.The swg was able to advance; no blood exited with the swg.A small set of grooves were felt along the outer lumen approximately 70.0cm from the distal tip at the area of the previously noted resistance.A kink was noted beneath the outer lumen on the central lumen at this location.The kink was likely the cause of the resistance felt with the swg.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 central lumen was occluded is confirmed.A kink on the central lumen was found and some dried blood was noted on the returned swg upon removal.The root cause of the kink is undetermined.

Event Description

It was reported that intra-aortic balloon pump (iabp) therapy was to be used for cardiac support.While in the intensive care unit and during insertion of the intra-aortic balloon (iab) via a sheath in the patient's right femoral artery, the clinician tried to aspirate blood from the central lumen of the catheter but failed.The iab was removed and another iab was not inserted.The patient was kept under close observation.There was a reported delay / interruption in iabp therapy however the timeframe is not available.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is stable.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: INTRA-AORTIC BALLOON
• 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: 5467247
• MDR Text Key: 39257194
• Report Number: 1219856-2016-00049
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F14C0003
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• 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: 79 YR