MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA-AORTIC BALLOON FIBER OPTIC SYS

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event occurred in the cath lab.The intra-aortic balloon (iab) was inserted into the patient's left femoral artery via a sheath.Immediately after insertion, blood appeared in the driveline tubing.The iab was removed and not replaced.The cardiac perfusion team lead stated that "the balloon ruptured at the distal tip, very small pin like hole, but enough for blood to leak back into the balloon driveline tubing." there was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.Additional information received stated that the outcome of the patient was ok.The md decided that the patient did not require intra-aortic balloon pump (iabp) therapy.It was noted that the pump used was the iap-0500 , s/n (b)(4).

Manufacturer Narrative

(b)(4).Evaluation: the sample was returned with the supplied return kit.Upon return the short driveline tubing was cut off at the iab bifurcate.The one-way valve was not returned.The distal end of the teflon sheath was approximately 27.0cm from the iab distal tip.Some fluid was noted inside the sheath sidearm.The teflon sheath was connected to the hemostasis cuff which was connected to the cathgard.Blood was noted on the exterior of the bladder and outer lumen and on the interior of the bladder and short driveline tubing.The bladder was fully unwrapped.A bend was noted approximately 5.7cm from iab distal tip.The fos connector and cal key were examined.The fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue slide housing was examined and no abnormalities were noted.The cal key was intact.The one-way valve was not returned with the sample; therefore it could not be tested.The cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approximately 1.3cm from iab distal tip.The iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1.4cm from the distal tip of the iab.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 5.8cm from the iab distal tip.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.Resistance was noted at approximately 77.2cm from the iab luer.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.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 blood in helium pathway is confirmed.A puncture consistent with contact from the broken fiber was found near the distal tip of the iab which likely allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.

Event Description

It was reported that the event occurred in the cath lab.The intra-aortic balloon (iab) was inserted into the patient's left femoral artery via a sheath.Immediately after insertion , blood appeared in the driveline tubing.The iab was removed and not replaced.The cardiac perfusion team lead stated that "the balloon ruptured at the distal tip, very small pin like hole, but enough for blood to leak back into the balloon driveline tubing." there was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.Additional information received stated that the outcome of the patient was ok.The md decided that the patient did not require intra-aortic balloon pump (iabp) therapy.It was noted that the pump used was the iap-0500 , s/n (b)(4).

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYS
• 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: 5647954
• MDR Text Key: 45041805
• Report Number: 1219856-2016-00102
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021462
• 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
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18R14M0026
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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