MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06840-U

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported by the cath lab staff that the catheter was not draining.Additional information received stated that the patient (pt) was receiving intra-aortic balloon pump (iabp) therapy when the pt left the cath lab.However, by the time the pt arrived in the cardiac care unit (ccu) it was not working and there "might have been some clotting." it was noted that "there was a clot on the balloon when removed." the intra-aortic balloon (iab) was removed and replaced.The pt received iabp therapy as scheduled.The second iab was inserted into the same insertion site.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The iabp therapy was interrupted / delayed; however, there was no harm reported.The pt outcome is listed as "no issue.".

Manufacturer Narrative

Qn#(b)(4).No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is unable to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported by the cath lab staff that the catheter was not draining.Additional information received stated that the patient (pt) was receiving intra-aortic balloon pump (iabp) therapy when the pt left the cath lab.However, by the time the pt arrived in the cardiac care unit (ccu) it was not working and there "might have been some clotting." it was noted that "there was a clot on the balloon when removed." the intra-aortic balloon (iab) was removed and replaced.The pt received iabp therapy as scheduled.The second iab was inserted into the same insertion site.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The iabp therapy was interrupted / delayed however, there was no harm reported.The pt outcome is listed as "no issue.".

Manufacturer Narrative

(b)(4) on 07-july-2016 a medwatch was received.The reporter stated, intra-aortic balloon pump counterpulsation, balloon pump had no arterial waveform unable to flush, unable to aspirate blood from iabp, iabp pulled." report # mw5062658.Evaluation: returned for evaluation was a 40cc 7.5fr ultraflex iab.A 40cc inflation driveline tubing was connected to the iab short driveline tubing.A 10cc luer lock syringe, with approximately 4cc of fluid, was connected to the iab luer.The distal end of the teflon sheath was approximately 42.5cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Blood was observed on the exterior of the sheath, bifurcate, cathgard, outer lumen and bladder.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.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 catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.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 iab was connected to an iabp with the returned 40cc driveline tubing.The iab was inserted into the "t" tube and 100mmhg backpressure was applied.The iab was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A device history record (dhr) 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 of central lumen occluded is not confirmed.The central lumen was able to be aspirated and flushed upon return.The iab passed functional testing.The root cause of the reported complaint is undetermined.

Event Description

It was reported by the cath lab staff that the catheter was not draining.Additional information received stated that the patient (pt) was receiving intra-aortic balloon pump (iabp) therapy when the pt left the cath lab.However, by the time the pt arrived in the cardiac care unit (ccu) it was not working and there "might have been some clotting." it was noted that "there was a clot on the balloon when removed." the intra-aortic balloon (iab) was removed and replaced.The pt received iabp therapy as scheduled.The second iab was inserted into the same insertion site.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The iabp therapy was interrupted / delayed however, there was no harm reported.The pt outcome is listed as "no issue.".

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5672717
• MDR Text Key: 45704217
• Report Number: 1219856-2016-00120
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2016

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: 01/31/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F15M0035
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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