MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-S840C

Device Problem Difficult to Insert (1316)

Patient Problem Heart Failure (2206)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

See manufacture report number 1219856-2016-00142 ((b)(4)) for the first report.It was reported that the event involved a 164cm in height patient.While in the (icu) intensive care unit the (iab) intra-aortic balloon catheter was prepped, the second sheath was inserted into the patient's left femoral artery.When advancing iab catheter into the sheath, the clinician felt resistance.Therefore, the iab catheter with sheath was withdrawn.An (b)(4) kit was opened, prepped and inserted into the patient's left femoral artery successfully.There was no reported patient death injury or complications.There was a delay / interruption in iabp therapy however no harm to the patient was reported.The patient outcome is listed as: "keep observation".On 06/06/2016 additional information was received.The iab was prepped per the ifu.The iab membrane did not begin to unwrap prematurely prior to insertion.The md did not use the same swg.

Manufacturer Narrative

Qn#(b)(4).The serial number ((b)(4)) reported on the complaint report does not match the serial number on the returned sample.However, the customer pictures show the iab sample with a serial number of (b)(4).The serial number of the returned sample is (b)(4).Returned for evaluation was a 40cc 8.0fr rediguard iab with original packaging.The original packaging upc label did not match the returned sample.The sample was returned in an insertion kit tray packaging.Upon return, dried blood was noted on the exterior of the bladder, outer lumen and bifurcate.The hemostasis cuff was connected to the cathgard.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The bladder thickness was measured at six points with measurements within specification.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.Other remarks: a lab inventory 0.025in guidewire was back loaded through iab distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iab luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.Conclusion: the reported complaint of insertion difficulty is not confirmed.The iab passed functional testing.No sheath was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

See manufacture report number 1219856-2016-00142 (tc1900046029) for the first report.It was reported that the event involved a 164cm in height patient.While in the (icu) intensive care unit the (iab) intra-aortic balloon catheter was prepped, the second sheath was inserted into the patient's left femoral artery.When advancing iab catheter into the sheath, the clinician felt resistance.Therefore, the iab catheter with sheath was withdrawn.An iab-06840-u kit was opened, prepped and inserted into the patient's left femoral artery successfully.There was no reported patient death injury or complications.There was a delay / interruption in iabp therapy however no harm to the patient was reported.The patient outcome is listed as: "keep observation".On 06/06/2016 additional information was received.The iab was prepped per the ifu.The iab membrane did not begin to unwrap prematurely prior to insertion.The md did not use the same swg.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5763112
• MDR Text Key: 48630743
• Report Number: 1219856-2016-00143
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 07/31/2017
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F15G0018
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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
• Patient Age: 68 YR
• Patient Weight: 45