MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06830-U

Device Problem Material Rupture (1546)

Patient Problem Glaucoma (1875)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reference mdr #1219856-2016-00056 for the first event and mdr #1219856-2016-00058 for the second event involving the same patient.It was reported that at 14:00 on (b)(6) 2016 the intra-aortic balloon (iab) catheter was inserted into the patient.Soon after placement of the catheter, drain failure occurred and the alarm went off; however, the drainage was not confirmed in the bottle.At 17:00 the alarm stopped; drainage was confirmed in the drain bottle.At 19:00 the intra-aortic balloon pump ((b)(4)) was replaced by a new pump ((b)(4)) and the iab catheter was used as is.At 07:40 on (b)(6) 2016 the iab catheter and pump were removed.At 17:00, the clinical engineer (ce) checked the removed iab catheter and found two ruptures in the catheter; however, it was unknown when the ruptures occurred.The rn stated that the pump did not alarm during the procedure.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.The patient outcome is listed as good.Additional information received from the sales representative stated that the catheter was removed because therapy finished.

Manufacturer Narrative

(b)(4) device evaluation: returned for evaluation was a 30cc 7.5fr ultraflex iab.The short driveline tubing was connected to a 30cc inflation driveline tubing.The teflon sheath was approximately 39.2cm from the iab distal tip and was connected to the iab hemostasis cuff.The iab hemostasis cuff was connected to the cathgard.The iab assembly had the pressure line connected to the iab luer.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Blood was observed on the interior of the bladder, short driveline tubing and 30cc inflation driveline tubing.Bends were noted at approximately 4.9cm and 18.7cm from the iab distal tip.The bladder thickness was measured at various locations and was 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.A leak/puncture was noted approximately 2.8cm from the iab distal tip.Under microscopic investigation, a puncture to the bladder membrane was confirmed and the appearance was consistent with contact with a sharp.See other remarks section for continuation.Other remarks: a lab-inventory 0.025 inch spring wire guide (swg) was back loaded through the iab distal tip.Resistance was noted at approximately 6.0cm, 18.9cm and 68.5cm from the iab distal tip.The swg was able to advance through the central lumen; no blood or debris was noted.The swg was front loaded through the iab luer.Resistance was noted at approximately 9.4cm and 58.5cm from the iab luer.The swg 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 field corrective action was issued for this lot number on february 9, 2016.The reported event occurred after the field corrective action went live.The returned sample was not found with this issue.A device history record review was conducted for the lot number/serial number with one relevant finding.The component was manufactured prior to the field correction action recall for sheath hub separation (capa (b)(4)).The product was not found with this issue.Conclusion: the reported complaint of blood in helium pathway is confirmed.The bladder membrane had a puncture consistent with contact from a sharp which allowed blood to enter the iab.The root cause of the puncture is undetermined.

Event Description

Reference mdr #1219856-2016-00056 for the first event and mdr #1219856-2016-00058 for the second event involving the same patient.It was reported that at 14:00 on (b)(6) 2016 the intra-aortic balloon (iab) catheter was inserted into the patient.Soon after placement of the catheter, drain failure occurred and the alarm went off; however, the drainage was not confirmed in the bottle.At 17:00 the alarm stopped; drainage was confirmed in the drain bottle.At 19:00 the intra-aortic balloon pump ((b)(4)) was replaced by a new pump ((b)(4)) and the iab catheter was used as is.At 07:40 on (b)(6) 2016 the iab catheter and pump were removed.At 17:00, the clinical engineer (ce) checked the removed iab catheter and found two ruptures in the catheter; however, it was unknown when the ruptures occurred.The rn stated that the pump did not alarm during the procedure.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.The patient outcome is listed as good.Additional information received from the sales representative stated that the catheter was removed because therapy finished.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 5484127
• MDR Text Key: 39801913
• Report Number: 1219856-2016-00059
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

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: 02/28/2017
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F15B0006
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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: 69 YR
• Patient Weight: 55